{"id":9007,"date":"2025-10-02T09:16:28","date_gmt":"2025-10-02T09:16:28","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?page_id=9007"},"modified":"2026-08-01T06:26:03","modified_gmt":"2026-08-01T06:26:03","slug":"kitler","status":"publish","type":"page","link":"https:\/\/www.kalitekit.com.tr\/en\/kitler\/","title":{"rendered":"K\u0130TLER"},"content":{"rendered":"<section class=\"kkdt-shell kkdt-hub-v2\" data-kkdt-hub>\n            <header class=\"kkdt-hub-hero\">\n                <div class=\"kkdt-hub-hero-copy\">\n                    <span class=\"kkdt-eyebrow\">KaliteKit \u00b7 Dijital Reg\u00fclasyon Ara\u00e7lar\u0131<\/span>\n                    <h1>T\u0131bbi Cihaz Dijital Ara\u00e7lar\u0131 ve Mevzuat Kitleri<\/h1>\n                    <p>MDR, IVDR, UDI, ISO 14971, teknik dosya ve mikrobiyoloji s\u00fcre\u00e7lerinde ne yapman\u0131z gerekti\u011fini g\u00f6r\u00fcn; \u00e7al\u0131\u015fman\u0131z\u0131 yap\u0131land\u0131r\u0131n ve uygun ara\u00e7larda profesyonel \u00e7\u0131kt\u0131lar olu\u015fturun.<\/p>\n                    <div class=\"kkdt-hero-assurances\"><span>\u2713 Mevzuat odakl\u0131 i\u015f ak\u0131\u015flar\u0131<\/span><span>\u2713 Hesaba ba\u011fl\u0131 g\u00fcvenli eri\u015fim<\/span><span>\u2713 \u0130ndirilebilir profesyonel \u00e7\u0131kt\u0131lar<\/span><\/div>\n                <\/div>\n                <aside class=\"kkdt-hub-account\">\n                    <span>Mevcut eri\u015fiminiz<\/span>\n                    <strong>\u00dccretsiz<\/strong>\n                    <div><b>26<\/b><small>aktif ara\u00e7<\/small><b>9<\/b><small>profesyonel \u00e7\u00f6z\u00fcm<\/small><\/div>\n                                            <a href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/kitler\/\">\u00dccretsiz hesap olu\u015ftur <span>\u2192<\/span><\/a>\n                                    <\/aside>\n            <\/header>\n\n            <div class=\"kkdt-value-path\" aria-label=\"KaliteKit dijital ara\u00e7 kullan\u0131m ak\u0131\u015f\u0131\">\n                <div><span><svg viewbox=\"0 0 24 24\"><circle cx=\"11\" cy=\"11\" r=\"6\"><\/circle><path d=\"m16 16 4 4\"><\/path><\/svg><\/span><p><strong>Do\u011fru arac\u0131 se\u00e7in<\/strong><small>S\u00fcrecinize ve ihtiyac\u0131n\u0131za uygun \u00e7\u00f6z\u00fcm\u00fc bulun.<\/small><\/p><\/div>\n                <div><span><svg viewbox=\"0 0 24 24\"><path d=\"M9 5h11M9 12h11M9 19h11M4 5l1 1 2-2M4 12l1 1 2-2M4 19l1 1 2-2\"><\/path><\/svg><\/span><p><strong>Ad\u0131m ad\u0131m tamamlay\u0131n<\/strong><small>Yap\u0131land\u0131r\u0131lm\u0131\u015f alanlarla kritik bilgileri atlamay\u0131n.<\/small><\/p><\/div>\n                <div><span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg><\/span><p><strong>\u00c7\u0131kt\u0131n\u0131z\u0131 olu\u015fturun<\/strong><small>Uygun ara\u00e7larda rapor, matris, barkod veya taslak al\u0131n.<\/small><\/p><\/div>\n            <\/div>\n\n                            <section class=\"kkdt-spotlight\">\n                    <div class=\"kkdt-section-heading\"><div><span>\u00d6ne \u00e7\u0131kan profesyonel \u00e7\u00f6z\u00fcmler<\/span><h2>En \u00e7ok ihtiya\u00e7 duyulan s\u00fcre\u00e7leri h\u0131zland\u0131r\u0131n<\/h2><\/div><p>Tek ara\u00e7 olarak sat\u0131n al\u0131n veya Profesyonel \u00fcyelik kapsam\u0131ndan yararlan\u0131n.<\/p><\/div>\n                    <div class=\"kkdt-spotlight-grid\">\n                                                    <a class=\"kkdt-spotlight-card\" href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/mdr-teknik-dosya-kontrol-kit\/\" aria-label=\"MDR Teknik Dosya Kontrol\u00fc \u2014 \u00dccretsiz Dene\">\n                                <div class=\"kkdt-spotlight-top\"><span><svg viewbox=\"0 0 24 24\"><path d=\"M9 5h11M9 12h11M9 19h11M4 5l1 1 2-2M4 12l1 1 2-2M4 19l1 1 2-2\"><\/path><\/svg><\/span><small>MDR<\/small><\/div>\n                                <h3>MDR Teknik Dosya Kontrol\u00fc<\/h3>\n                                <p>MDR Ek II ve Ek III gerekliliklerini kan\u0131t, sorumluluk ve aksiyon d\u00fczeyinde kontrol ederek denetim haz\u0131rl\u0131k raporu olu\u015fturun.<\/p>\n                                <ul><li>\u2713 Ek II\u2013III kontrol matrisi<\/li><li>\u2713 Kritik bo\u015fluk tespiti<\/li><li>\u2713 Aksiyon plan\u0131<\/li><\/ul>\n                                <div class=\"kkdt-spotlight-footer\"><strong>G\u00fcnde 3 \u00fccretsiz kullan\u0131m<\/strong><span>\u00dccretsiz Dene \u2192<\/span><\/div>\n                            <\/a>\n                                                    <a class=\"kkdt-spotlight-card\" href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/iso-14971-bazli-risk-analiz-araci\/\" aria-label=\"ISO 14971 Risk Analizi \u2014 \u00dccretsiz Dene\">\n                                <div class=\"kkdt-spotlight-top\"><span><svg viewbox=\"0 0 24 24\"><path d=\"M12 3 2 21h20L12 3Z\"><\/path><path d=\"M12 9v5M12 18h.01\"><\/path><\/svg><\/span><small>Kalite<\/small><\/div>\n                                <h3>ISO 14971 Risk Analizi<\/h3>\n                                <p>Tehlike\u2013\u00f6ng\u00f6r\u00fclebilir olay dizisi\u2013tehlikeli durum\u2013zarar ili\u015fkisini risk kontrolleri ve art\u0131k risk kan\u0131tlar\u0131yla y\u00f6netin.<\/p>\n                                <ul><li>\u2713 Sekmeli risk i\u015f ak\u0131\u015f\u0131<\/li><li>\u2713 Ba\u015flang\u0131\u00e7\/art\u0131k risk<\/li><li>\u2713 Kontrol hiyerar\u015fisi<\/li><\/ul>\n                                <div class=\"kkdt-spotlight-footer\"><strong>G\u00fcnde 3 \u00fccretsiz kullan\u0131m<\/strong><span>\u00dccretsiz Dene \u2192<\/span><\/div>\n                            <\/a>\n                                                    <a class=\"kkdt-spotlight-card\" href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/premium-udi\/\" aria-label=\"UDI Kod Olu\u015fturucu \u2014 \u00dccretsiz Dene\">\n                                <div class=\"kkdt-spotlight-top\"><span><svg viewbox=\"0 0 24 24\"><path d=\"M14 6a4 4 0 0 0-5 5L3 17l4 4 6-6a4 4 0 0 0 5-5l-3 3-4-4 3-3Z\"><\/path><\/svg><\/span><small>EUDAMED &amp; UDI<\/small><\/div>\n                                <h3>UDI Kod Olu\u015fturucu<\/h3>\n                                <p>GS1 taraf\u0131ndan tahsis edilmi\u015f verilerinizi kullanarak barkod okuyucularla uyumlu UDI ta\u015f\u0131y\u0131c\u0131lar\u0131n\u0131 kontroll\u00fc bi\u00e7imde \u00fcretin.<\/p>\n                                <ul><li>\u2713 GS1 veri do\u011frulamas\u0131<\/li><li>\u2713 GS1-128 ve DataMatrix<\/li><li>\u2713 Etiket \u00f6nizlemesi<\/li><\/ul>\n                                <div class=\"kkdt-spotlight-footer\"><strong>G\u00fcnde 3 \u00fccretsiz kullan\u0131m<\/strong><span>\u00dccretsiz Dene \u2192<\/span><\/div>\n                            <\/a>\n                                            <\/div>\n                <\/section>\n            \n            <div class=\"kkdt-catalog-head\"><div><span>T\u00fcm dijital ara\u00e7lar<\/span><h2>\u0130htiyac\u0131n\u0131za uygun arac\u0131 bulun<\/h2><p>17 \u00fccretsiz\/\u00fcye arac\u0131 ve 9 profesyonel \u00e7\u00f6z\u00fcm\u00fc tek katalogda inceleyin.<\/p><\/div><div class=\"kkdt-access-legend\"><span><i class=\"is-free\"><\/i>\u00dccretsiz<\/span><span><i class=\"is-member\"><\/i>\u00dccretsiz \u00dcye<\/span><span><i class=\"is-paid\"><\/i>\u00dccretli<\/span><\/div><\/div>\n\n            <div class=\"kkdt-toolbar kkdt-toolbar-v2\">\n                <label class=\"kkdt-search\">\n                    <span class=\"screen-reader-text\">Ara\u00e7larda ara<\/span>\n                    <input type=\"search\" placeholder=\"Ara\u00e7, mevzuat veya s\u00fcre\u00e7 ara: MDR, IVDR, UDI, risk...\" data-kkdt-search>\n                <\/label>\n                <div class=\"kkdt-filters\" role=\"group\" aria-label=\"Ara\u00e7 kategorileri\">\n                    <button type=\"button\" class=\"is-active\" data-kkdt-filter=\"all\">T\u00fcm\u00fc<\/button>\n                                            <button type=\"button\" data-kkdt-filter=\"dogrulama\">Do\u011frulama<\/button>\n                                            <button type=\"button\" data-kkdt-filter=\"eudamed-udi\">EUDAMED &amp; UDI<\/button>\n                                            <button type=\"button\" data-kkdt-filter=\"egitim\">E\u011fitim<\/button>\n                                            <button type=\"button\" data-kkdt-filter=\"ivdr\">IVDR<\/button>\n                                            <button type=\"button\" data-kkdt-filter=\"kalite\">Kalite<\/button>\n                                            <button type=\"button\" data-kkdt-filter=\"mdr\">MDR<\/button>\n                                            <button type=\"button\" data-kkdt-filter=\"mikrobiyoloji\">Mikrobiyoloji<\/button>\n                                            <button type=\"button\" data-kkdt-filter=\"pms\">PMS<\/button>\n                                            <button type=\"button\" data-kkdt-filter=\"regulasyon\">Reg\u00fclasyon<\/button>\n                                            <button type=\"button\" data-kkdt-filter=\"uts\">\u00dcTS<\/button>\n                                    <\/div>\n            <\/div>\n\n            <div class=\"kkdt-grid kkdt-catalog-grid\">\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-open is-public\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/emdn-kod-arama-kiti\/\"\n                             data-kkdt-card\n data-category=\"eudamed-udi\"\n                             data-search=\"emdn kod arama eudamed ve teknik dok\u00fcmantasyon i\u00e7in emdn kodlar\u0131n\u0131 inceleyin. eudamed &amp; udi cihaz\u0131n\u0131za uygun emdn kodunu teknik dosya ve eudamed haz\u0131rl\u0131\u011f\u0131 \u00f6ncesinde h\u0131zl\u0131ca ara\u015ft\u0131r\u0131n. kod ve ba\u015fl\u0131klar\u0131 anahtar kelimeyle taray\u0131n aday kodlar\u0131 kapsamlar\u0131yla kar\u015f\u0131la\u015ft\u0131r\u0131n kay\u0131t \u00f6ncesi kod \u00e7al\u0131\u015fman\u0131z\u0131 h\u0131zland\u0131r\u0131n aday emdn kod listesi\"\n                             aria-label=\"EMDN Kod Arama \u2014 Arac\u0131 A\u00e7\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><circle cx=\"11\" cy=\"11\" r=\"6\"><\/circle><path d=\"m16 16 4 4\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-public\">\u00dccretsiz<\/span>\n                        <\/div>\n                        <h2>EMDN Kod Arama<\/h2>\n                        <p class=\"kkdt-card-lead\">Cihaz\u0131n\u0131za uygun EMDN kodunu teknik dosya ve EUDAMED haz\u0131rl\u0131\u011f\u0131 \u00f6ncesinde h\u0131zl\u0131ca ara\u015ft\u0131r\u0131n.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Kod ve ba\u015fl\u0131klar\u0131 anahtar kelimeyle taray\u0131n<\/li><li><span>\u2713<\/span>Aday kodlar\u0131 kapsamlar\u0131yla kar\u015f\u0131la\u015ft\u0131r\u0131n<\/li><li><span>\u2713<\/span>Kay\u0131t \u00f6ncesi kod \u00e7al\u0131\u015fman\u0131z\u0131 h\u0131zland\u0131r\u0131n<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Aday EMDN kod listesi<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-open\">\n                                <span aria-hidden=\"true\">\u2713<\/span>\n                                <div><small>Kullan\u0131ma haz\u0131r<\/small><strong>Kay\u0131t olmadan hemen kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>EUDAMED &amp; UDI<\/b><small>Kay\u0131t gerektirmez<\/small><\/span>\n                            <strong>Arac\u0131 A\u00e7 <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-member\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/tibbi-cihaz-siniflandirma-araci\/\"\n                             data-kkdt-card\n data-category=\"mdr\"\n                             data-search=\"mdr s\u0131n\u0131fland\u0131rma mdr annex viii kurallar\u0131na g\u00f6re \u00f6n s\u0131n\u0131fland\u0131rma ger\u00e7ekle\u015ftirin. mdr cihaz \u00f6zelliklerini mdr ek viii kurallar\u0131yla e\u015fle\u015ftirerek aday risk s\u0131n\u0131f\u0131n\u0131 ve dayanak kural\u0131 g\u00f6r\u00fcn. kullan\u0131m s\u00fcresi ve invazivlik sorular\u0131n\u0131 yan\u0131tlay\u0131n \u00d6zel s\u0131n\u0131fland\u0131rma durumlar\u0131n\u0131 kontrol edin sonucu gerek\u00e7esiyle birlikte inceleyin \u00d6n s\u0131n\u0131fland\u0131rma sonucu kural gerek\u00e7esi\"\n                             aria-label=\"MDR S\u0131n\u0131fland\u0131rma \u2014 \u00dccretsiz Hesap Olu\u015ftur\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"m12 3 9 5-9 5-9-5 9-5Z\"><\/path><path d=\"m3 12 9 5 9-5M3 16l9 5 9-5\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-member\">\u00dccretsiz \u00dcye<\/span>\n                        <\/div>\n                        <h2>MDR S\u0131n\u0131fland\u0131rma<\/h2>\n                        <p class=\"kkdt-card-lead\">Cihaz \u00f6zelliklerini MDR Ek VIII kurallar\u0131yla e\u015fle\u015ftirerek aday risk s\u0131n\u0131f\u0131n\u0131 ve dayanak kural\u0131 g\u00f6r\u00fcn.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Kullan\u0131m s\u00fcresi ve invazivlik sorular\u0131n\u0131 yan\u0131tlay\u0131n<\/li><li><span>\u2713<\/span>\u00d6zel s\u0131n\u0131fland\u0131rma durumlar\u0131n\u0131 kontrol edin<\/li><li><span>\u2713<\/span>Sonucu gerek\u00e7esiyle birlikte inceleyin<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>\u00d6n s\u0131n\u0131fland\u0131rma sonucu<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Kural gerek\u00e7esi<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz \u00fcyelik<\/small><strong>Hesap olu\u015fturun ve \u00fccretsiz kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>MDR<\/b><small>\u00dccretsiz \u00fcyelikle eri\u015fim<\/small><\/span>\n                            <strong>\u00dccretsiz Hesap Olu\u015ftur <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-professional\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/mdr-teknik-dosya-kontrol-kit\/\"\n                             data-kkdt-card\n data-category=\"mdr\"\n                             data-search=\"mdr teknik dosya kontrol\u00fc annex ii ve iii kapsam\u0131ndaki teknik dok\u00fcmantasyon ba\u015fl\u0131klar\u0131n\u0131 kontrol edin. mdr mdr ek ii ve ek iii gerekliliklerini kan\u0131t, sorumluluk ve aksiyon d\u00fczeyinde kontrol ederek denetim haz\u0131rl\u0131k raporu olu\u015fturun. ek ii\u2013iii kontrol matrisi kritik bo\u015fluk tespiti aksiyon plan\u0131 kaydedilebilir \u00e7al\u0131\u015fma teknik dosya uygunluk \u00f6zeti eksiklik ve aksiyon listesi yazd\u0131r\u0131labilir denetim raporu\"\n                             aria-label=\"MDR Teknik Dosya Kontrol\u00fc \u2014 \u00dccretsiz Dene\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M9 5h11M9 12h11M9 19h11M4 5l1 1 2-2M4 12l1 1 2-2M4 19l1 1 2-2\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-professional\">\u00dccretsiz deneme<\/span>\n                        <\/div>\n                        <h2>MDR Teknik Dosya Kontrol\u00fc<\/h2>\n                        <p class=\"kkdt-card-lead\">MDR Ek II ve Ek III gerekliliklerini kan\u0131t, sorumluluk ve aksiyon d\u00fczeyinde kontrol ederek denetim haz\u0131rl\u0131k raporu olu\u015fturun.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Ek II\u2013III kontrol matrisi<\/li><li><span>\u2713<\/span>Kritik bo\u015fluk tespiti<\/li><li><span>\u2713<\/span>Aksiyon plan\u0131<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Teknik dosya uygunluk \u00f6zeti<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Eksiklik ve aksiyon listesi<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz deneme<\/small><strong>\u00dccretsiz hesapla g\u00fcnl\u00fck 3 kullan\u0131m<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>MDR<\/b><small>G\u00fcnde 3 \u00fccretsiz kullan\u0131m<\/small><\/span>\n                            <strong>\u00dccretsiz Dene <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-member\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/sinif-bazli-onay-yolu-rehberi\/\"\n                             data-kkdt-card\n data-category=\"mdr\"\n                             data-search=\"mdr onay yolu cihaz s\u0131n\u0131f\u0131na ba\u011fl\u0131 uygunluk de\u011ferlendirme yolunu \u00f6n de\u011ferlendirin. mdr cihaz s\u0131n\u0131f\u0131n\u0131za g\u00f6re uygunluk de\u011ferlendirme yolunu ve onaylanm\u0131\u015f kurulu\u015f gereksinimini \u00f6n de\u011ferlendirin. s\u0131n\u0131fa uygun de\u011ferlendirme yolunu g\u00f6r\u00fcn onaylanm\u0131\u015f kurulu\u015f kat\u0131l\u0131m\u0131n\u0131 anlay\u0131n temel mdr ad\u0131mlar\u0131n\u0131 s\u0131ralay\u0131n onay yolu \u00f6zeti ad\u0131m listesi\"\n                             aria-label=\"MDR Onay Yolu \u2014 \u00dccretsiz Hesap Olu\u015ftur\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><circle cx=\"6\" cy=\"18\" r=\"2\"><\/circle><circle cx=\"18\" cy=\"6\" r=\"2\"><\/circle><path d=\"M8 18h3a4 4 0 0 0 4-4v-4a2 2 0 0 1 2-2\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-member\">\u00dccretsiz \u00dcye<\/span>\n                        <\/div>\n                        <h2>MDR Onay Yolu<\/h2>\n                        <p class=\"kkdt-card-lead\">Cihaz s\u0131n\u0131f\u0131n\u0131za g\u00f6re uygunluk de\u011ferlendirme yolunu ve onaylanm\u0131\u015f kurulu\u015f gereksinimini \u00f6n de\u011ferlendirin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>S\u0131n\u0131fa uygun de\u011ferlendirme yolunu g\u00f6r\u00fcn<\/li><li><span>\u2713<\/span>Onaylanm\u0131\u015f kurulu\u015f kat\u0131l\u0131m\u0131n\u0131 anlay\u0131n<\/li><li><span>\u2713<\/span>Temel MDR ad\u0131mlar\u0131n\u0131 s\u0131ralay\u0131n<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Onay yolu \u00f6zeti<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Ad\u0131m listesi<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz \u00fcyelik<\/small><strong>Hesap olu\u015fturun ve \u00fccretsiz kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>MDR<\/b><small>\u00dccretsiz \u00fcyelikle eri\u015fim<\/small><\/span>\n                            <strong>\u00dccretsiz Hesap Olu\u015ftur <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-member\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/mdr-uyum-skoru-testi\/\"\n                             data-kkdt-card\n data-category=\"mdr\"\n                             data-search=\"mdr uyum skoru testi kan\u0131t odakl\u0131 kontrollerle mdr haz\u0131rl\u0131k seviyesini, kritik bo\u015fluklar\u0131 ve \u00f6ncelikli eylemleri de\u011ferlendirin. mdr mdr haz\u0131rl\u0131k seviyenizi kan\u0131t odakl\u0131 sorularla \u00f6l\u00e7\u00fcn; kritik bo\u015fluklar\u0131 ve \u00f6ncelikli i\u015fleri g\u00f6r\u00fcn. 24 temel gereklili\u011fi de\u011ferlendirin kategori bazl\u0131 haz\u0131rl\u0131k skorunu g\u00f6r\u00fcn kritik a\u00e7\u0131klar\u0131 \u00f6nceliklendirin mdr uyum skoru \u00d6ncelikli eylem \u00f6zeti\"\n                             aria-label=\"MDR Uyum Skoru Testi \u2014 \u00dccretsiz Hesap Olu\u015ftur\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M4 20V10M10 20V4M16 20v-7M22 20H2\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-member\">\u00dccretsiz \u00dcye<\/span>\n                        <\/div>\n                        <h2>MDR Uyum Skoru Testi<\/h2>\n                        <p class=\"kkdt-card-lead\">MDR haz\u0131rl\u0131k seviyenizi kan\u0131t odakl\u0131 sorularla \u00f6l\u00e7\u00fcn; kritik bo\u015fluklar\u0131 ve \u00f6ncelikli i\u015fleri g\u00f6r\u00fcn.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>24 temel gereklili\u011fi de\u011ferlendirin<\/li><li><span>\u2713<\/span>Kategori bazl\u0131 haz\u0131rl\u0131k skorunu g\u00f6r\u00fcn<\/li><li><span>\u2713<\/span>Kritik a\u00e7\u0131klar\u0131 \u00f6nceliklendirin<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>MDR uyum skoru<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>\u00d6ncelikli eylem \u00f6zeti<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz \u00fcyelik<\/small><strong>Hesap olu\u015fturun ve \u00fccretsiz kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>MDR<\/b><small>\u00dccretsiz \u00fcyelikle eri\u015fim<\/small><\/span>\n                            <strong>\u00dccretsiz Hesap Olu\u015ftur <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-professional\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/premium-udi\/\"\n                             data-kkdt-card\n data-category=\"eudamed-udi\"\n                             data-search=\"udi kod olu\u015fturucu udi-di, udi-pi ve barkod verilerini kontroll\u00fc bi\u00e7imde haz\u0131rlay\u0131n. eudamed &amp; udi gs1 taraf\u0131ndan tahsis edilmi\u015f verilerinizi kullanarak barkod okuyucularla uyumlu udi ta\u015f\u0131y\u0131c\u0131lar\u0131n\u0131 kontroll\u00fc bi\u00e7imde \u00fcretin. gs1 veri do\u011frulamas\u0131 gs1-128 ve datamatrix etiket \u00f6nizlemesi y\u00fcksek kaliteli \u00e7\u0131kt\u0131 gs1-128 barkod gs1 datamatrix udi etiket \u00f6nizlemesi\"\n                             aria-label=\"UDI Kod Olu\u015fturucu \u2014 \u00dccretsiz Dene\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M14 6a4 4 0 0 0-5 5L3 17l4 4 6-6a4 4 0 0 0 5-5l-3 3-4-4 3-3Z\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-professional\">\u00dccretsiz deneme<\/span>\n                        <\/div>\n                        <h2>UDI Kod Olu\u015fturucu<\/h2>\n                        <p class=\"kkdt-card-lead\">GS1 taraf\u0131ndan tahsis edilmi\u015f verilerinizi kullanarak barkod okuyucularla uyumlu UDI ta\u015f\u0131y\u0131c\u0131lar\u0131n\u0131 kontroll\u00fc bi\u00e7imde \u00fcretin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>GS1 veri do\u011frulamas\u0131<\/li><li><span>\u2713<\/span>GS1-128 ve DataMatrix<\/li><li><span>\u2713<\/span>Etiket \u00f6nizlemesi<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>GS1-128 barkod<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>GS1 DataMatrix<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz deneme<\/small><strong>\u00dccretsiz hesapla g\u00fcnl\u00fck 3 kullan\u0131m<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>EUDAMED &amp; UDI<\/b><small>G\u00fcnde 3 \u00fccretsiz kullan\u0131m<\/small><\/span>\n                            <strong>\u00dccretsiz Dene <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-professional\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/iso-14971-bazli-risk-analiz-araci\/\"\n                             data-kkdt-card\n data-category=\"kalite\"\n                             data-search=\"iso 14971 risk analizi tehlike, zarar, kontrol ve art\u0131k risk kay\u0131tlar\u0131n\u0131 yap\u0131land\u0131r\u0131n. kalite tehlike\u2013\u00f6ng\u00f6r\u00fclebilir olay dizisi\u2013tehlikeli durum\u2013zarar ili\u015fkisini risk kontrolleri ve art\u0131k risk kan\u0131tlar\u0131yla y\u00f6netin. sekmeli risk i\u015f ak\u0131\u015f\u0131 ba\u015flang\u0131\u00e7\/art\u0131k risk kontrol hiyerar\u015fisi \u0130zlenebilir risk kayd\u0131 iso 14971 risk tablosu art\u0131k risk \u00f6zeti kontrol do\u011frulama kay\u0131t listesi\"\n                             aria-label=\"ISO 14971 Risk Analizi \u2014 \u00dccretsiz Dene\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M12 3 2 21h20L12 3Z\"><\/path><path d=\"M12 9v5M12 18h.01\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-professional\">\u00dccretsiz deneme<\/span>\n                        <\/div>\n                        <h2>ISO 14971 Risk Analizi<\/h2>\n                        <p class=\"kkdt-card-lead\">Tehlike\u2013\u00f6ng\u00f6r\u00fclebilir olay dizisi\u2013tehlikeli durum\u2013zarar ili\u015fkisini risk kontrolleri ve art\u0131k risk kan\u0131tlar\u0131yla y\u00f6netin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Sekmeli risk i\u015f ak\u0131\u015f\u0131<\/li><li><span>\u2713<\/span>Ba\u015flang\u0131\u00e7\/art\u0131k risk<\/li><li><span>\u2713<\/span>Kontrol hiyerar\u015fisi<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>ISO 14971 risk tablosu<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Art\u0131k risk \u00f6zeti<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz deneme<\/small><strong>\u00dccretsiz hesapla g\u00fcnl\u00fck 3 kullan\u0131m<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>Kalite<\/b><small>G\u00fcnde 3 \u00fccretsiz kullan\u0131m<\/small><\/span>\n                            <strong>\u00dccretsiz Dene <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-open is-public\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/mdcg-rehber-filtreyeci-turkce\/\"\n                             data-kkdt-card\n data-category=\"regulasyon\"\n                             data-search=\"mdcg rehber filtreleyici mdr ve ivdr rehberlerini konu ve s\u00fcre\u00e7 etkisine g\u00f6re filtreleyin. reg\u00fclasyon mdcg rehberlerini konu, mevzuat ve s\u00fcre\u00e7 etkisine g\u00f6re filtreleyerek do\u011fru kayna\u011fa daha h\u0131zl\u0131 ula\u015f\u0131n. mdr ve ivdr rehberlerini ay\u0131r\u0131n konuya g\u00f6re sonu\u00e7lar\u0131 daralt\u0131n \u0130lgili rehbere do\u011frudan ula\u015f\u0131n filtrelenmi\u015f mdcg rehber listesi\"\n                             aria-label=\"MDCG Rehber Filtreleyici \u2014 Arac\u0131 A\u00e7\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M14 6a4 4 0 0 0-5 5L3 17l4 4 6-6a4 4 0 0 0 5-5l-3 3-4-4 3-3Z\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-public\">\u00dccretsiz<\/span>\n                        <\/div>\n                        <h2>MDCG Rehber Filtreleyici<\/h2>\n                        <p class=\"kkdt-card-lead\">MDCG rehberlerini konu, mevzuat ve s\u00fcre\u00e7 etkisine g\u00f6re filtreleyerek do\u011fru kayna\u011fa daha h\u0131zl\u0131 ula\u015f\u0131n.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>MDR ve IVDR rehberlerini ay\u0131r\u0131n<\/li><li><span>\u2713<\/span>Konuya g\u00f6re sonu\u00e7lar\u0131 daralt\u0131n<\/li><li><span>\u2713<\/span>\u0130lgili rehbere do\u011frudan ula\u015f\u0131n<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Filtrelenmi\u015f MDCG rehber listesi<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-open\">\n                                <span aria-hidden=\"true\">\u2713<\/span>\n                                <div><small>Kullan\u0131ma haz\u0131r<\/small><strong>Kay\u0131t olmadan hemen kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>Reg\u00fclasyon<\/b><small>Kay\u0131t gerektirmez<\/small><\/span>\n                            <strong>Arac\u0131 A\u00e7 <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-member\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/gap-analizi\/\"\n                             data-kkdt-card\n data-category=\"kalite\"\n                             data-search=\"gap analizi kalite sistemi ve mevzuat haz\u0131rl\u0131k bo\u015fluklar\u0131n\u0131 de\u011ferlendirin. kalite mdr, ivdr veya iso 13485 kapsam\u0131n\u0131 se\u00e7erek mevcut durumunuzu gereklilik baz\u0131nda de\u011ferlendirin. kapsama uygun kontrol setini kullan\u0131n eksik ve k\u0131smi alanlar\u0131 g\u00f6r\u00fcn \u00d6ncelikli iyile\u015ftirme konular\u0131n\u0131 belirleyin gap haz\u0131rl\u0131k \u00f6zeti profesyonel rapor se\u00e7ene\u011fi\"\n                             aria-label=\"GAP Analizi \u2014 \u00dccretsiz Hesap Olu\u015ftur\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M14 6a4 4 0 0 0-5 5L3 17l4 4 6-6a4 4 0 0 0 5-5l-3 3-4-4 3-3Z\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-member\">\u00dccretsiz \u00dcye<\/span>\n                        <\/div>\n                        <h2>GAP Analizi<\/h2>\n                        <p class=\"kkdt-card-lead\">MDR, IVDR veya ISO 13485 kapsam\u0131n\u0131 se\u00e7erek mevcut durumunuzu gereklilik baz\u0131nda de\u011ferlendirin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Kapsama uygun kontrol setini kullan\u0131n<\/li><li><span>\u2713<\/span>Eksik ve k\u0131smi alanlar\u0131 g\u00f6r\u00fcn<\/li><li><span>\u2713<\/span>\u00d6ncelikli iyile\u015ftirme konular\u0131n\u0131 belirleyin<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>GAP haz\u0131rl\u0131k \u00f6zeti<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Profesyonel rapor se\u00e7ene\u011fi<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz \u00fcyelik<\/small><strong>Hesap olu\u015fturun ve \u00fccretsiz kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>Kalite<\/b><small>\u00dccretsiz \u00fcyelikle eri\u015fim<\/small><\/span>\n                            <strong>\u00dccretsiz Hesap Olu\u015ftur <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-professional\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/uygunluk-beyani-olusturucu\/\"\n                             data-kkdt-card\n data-category=\"mdr\"\n                             data-search=\"mdr uygunluk beyan\u0131 mdr annex iv tabanl\u0131, kontroll\u00fc ve izlenebilir ab uygunluk beyan\u0131 haz\u0131rlay\u0131n. mdr mdr ek iv zorunlu alanlar\u0131n\u0131 cihaz, \u00fcretici, uygunluk de\u011ferlendirme ve imza bilgileriyle kontroll\u00fc taslakta birle\u015ftirin. ek iv alan kontrol\u00fc cihaz ve basic udi-di nb ve sertifika kapsam\u0131 revizyon kontroll\u00fc taslak ab uygunluk beyan\u0131 tasla\u011f\u0131 kontrol edilebilir belge g\u00f6r\u00fcn\u00fcm\u00fc pdf\/yazd\u0131rma \u00e7\u0131kt\u0131s\u0131\"\n                             aria-label=\"MDR Uygunluk Beyan\u0131 \u2014 \u00dccretsiz Dene\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-professional\">\u00dccretsiz deneme<\/span>\n                        <\/div>\n                        <h2>MDR Uygunluk Beyan\u0131<\/h2>\n                        <p class=\"kkdt-card-lead\">MDR Ek IV zorunlu alanlar\u0131n\u0131 cihaz, \u00fcretici, uygunluk de\u011ferlendirme ve imza bilgileriyle kontroll\u00fc taslakta birle\u015ftirin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Ek IV alan kontrol\u00fc<\/li><li><span>\u2713<\/span>Cihaz ve Basic UDI-DI<\/li><li><span>\u2713<\/span>NB ve sertifika kapsam\u0131<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>AB Uygunluk Beyan\u0131 tasla\u011f\u0131<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Kontrol edilebilir belge g\u00f6r\u00fcn\u00fcm\u00fc<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz deneme<\/small><strong>\u00dccretsiz hesapla g\u00fcnl\u00fck 3 kullan\u0131m<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>MDR<\/b><small>G\u00fcnde 3 \u00fccretsiz kullan\u0131m<\/small><\/span>\n                            <strong>\u00dccretsiz Dene <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-professional\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/klinik-degerlendirme-karar-araci\/\"\n                             data-kkdt-card\n data-category=\"mdr\"\n                             data-search=\"klinik de\u011ferlendirme karar deste\u011fi klinik kan\u0131t bo\u015fluklar\u0131n\u0131 ve ara\u015ft\u0131rma gereklili\u011fi g\u00f6stergelerini de\u011ferlendirin. mdr cihaz riskini, \u00fcr\u00fcne \u00f6zg\u00fc klinik veriyi ve e\u015fde\u011ferlik eri\u015fimini birlikte de\u011ferlendirerek klinik kan\u0131t bo\u015fluklar\u0131n\u0131 \u00f6nceliklendirin. kan\u0131t yeterlilik analizi e\u015fde\u011ferlik eri\u015fimi ara\u015ft\u0131rma g\u00f6stergeleri \u00d6ncelikli eylem plan\u0131 klinik kan\u0131t bo\u015flu\u011fu raporu gerek\u00e7eli \u00f6ncelik listesi de\u011ferlendirme kayd\u0131\"\n                             aria-label=\"Klinik De\u011ferlendirme Karar Deste\u011fi \u2014 \u00dccretsiz Dene\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M14 6a4 4 0 0 0-5 5L3 17l4 4 6-6a4 4 0 0 0 5-5l-3 3-4-4 3-3Z\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-professional\">\u00dccretsiz deneme<\/span>\n                        <\/div>\n                        <h2>Klinik De\u011ferlendirme Karar Deste\u011fi<\/h2>\n                        <p class=\"kkdt-card-lead\">Cihaz riskini, \u00fcr\u00fcne \u00f6zg\u00fc klinik veriyi ve e\u015fde\u011ferlik eri\u015fimini birlikte de\u011ferlendirerek klinik kan\u0131t bo\u015fluklar\u0131n\u0131 \u00f6nceliklendirin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Kan\u0131t yeterlilik analizi<\/li><li><span>\u2713<\/span>E\u015fde\u011ferlik eri\u015fimi<\/li><li><span>\u2713<\/span>Ara\u015ft\u0131rma g\u00f6stergeleri<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Klinik kan\u0131t bo\u015flu\u011fu raporu<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Gerek\u00e7eli \u00f6ncelik listesi<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz deneme<\/small><strong>\u00dccretsiz hesapla g\u00fcnl\u00fck 3 kullan\u0131m<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>MDR<\/b><small>G\u00fcnde 3 \u00fccretsiz kullan\u0131m<\/small><\/span>\n                            <strong>\u00dccretsiz Dene <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-member\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/ivdr-teknik-dosya-gereklilik-kiti\/\"\n                             data-kkdt-card\n data-category=\"ivdr\"\n                             data-search=\"ivdr dok\u00fcmantasyon gereklilikleri cihaz s\u0131n\u0131f\u0131na g\u00f6re teknik dok\u00fcmantasyon kapsam\u0131n\u0131 g\u00f6r\u00fcnt\u00fcleyin. ivdr ivd s\u0131n\u0131f\u0131na g\u00f6re teknik dok\u00fcmantasyonda bulunmas\u0131 beklenen ana kan\u0131t ve kay\u0131t ba\u015fl\u0131klar\u0131n\u0131 g\u00f6r\u00fcn. s\u0131n\u0131fa g\u00f6re gereklilikleri ay\u0131r\u0131n performans ve pms kay\u0131tlar\u0131n\u0131 kontrol edin belge kapsam\u0131n\u0131 \u00f6nceden planlay\u0131n ivdr dok\u00fcman gereklilik listesi\"\n                             aria-label=\"IVDR Dok\u00fcmantasyon Gereklilikleri \u2014 \u00dccretsiz Hesap Olu\u015ftur\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M9 5h11M9 12h11M9 19h11M4 5l1 1 2-2M4 12l1 1 2-2M4 19l1 1 2-2\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-member\">\u00dccretsiz \u00dcye<\/span>\n                        <\/div>\n                        <h2>IVDR Dok\u00fcmantasyon Gereklilikleri<\/h2>\n                        <p class=\"kkdt-card-lead\">IVD s\u0131n\u0131f\u0131na g\u00f6re teknik dok\u00fcmantasyonda bulunmas\u0131 beklenen ana kan\u0131t ve kay\u0131t ba\u015fl\u0131klar\u0131n\u0131 g\u00f6r\u00fcn.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>S\u0131n\u0131fa g\u00f6re gereklilikleri ay\u0131r\u0131n<\/li><li><span>\u2713<\/span>Performans ve PMS kay\u0131tlar\u0131n\u0131 kontrol edin<\/li><li><span>\u2713<\/span>Belge kapsam\u0131n\u0131 \u00f6nceden planlay\u0131n<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>IVDR dok\u00fcman gereklilik listesi<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz \u00fcyelik<\/small><strong>Hesap olu\u015fturun ve \u00fccretsiz kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>IVDR<\/b><small>\u00dccretsiz \u00fcyelikle eri\u015fim<\/small><\/span>\n                            <strong>\u00dccretsiz Hesap Olu\u015ftur <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-professional\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/ivdr-pep-per-olusturucu\/\"\n                             data-kkdt-card\n data-category=\"ivdr\"\n                             data-search=\"ivdr pep ve per \u00c7al\u0131\u015fma alan\u0131 ivdr ek xiii kapsam\u0131nda bilimsel ge\u00e7erlilik, analitik ve klinik performans kan\u0131tlar\u0131n\u0131 planlay\u0131n; iddia\u2013kan\u0131t\u2013risk matrisi ve kontroll\u00fc pdf olu\u015fturun. ivdr bilimsel ge\u00e7erlilik, analitik performans ve klinik performans kan\u0131tlar\u0131n\u0131 ivdr ek xiii yap\u0131s\u0131nda izlenebilir bir pep\/per \u00e7al\u0131\u015fma alan\u0131nda y\u00f6netin. sekiz a\u015famal\u0131 \u00e7al\u0131\u015fma alan\u0131 \u0130ddia\u2013kan\u0131t\u2013risk matrisi eksiklik denetimi kontroll\u00fc pdf performans de\u011ferlendirme plan\u0131 performans de\u011ferlendirme raporu kan\u0131t ve izlenebilirlik ekleri\"\n                             aria-label=\"IVDR PEP ve PER \u00c7al\u0131\u015fma Alan\u0131 \u2014 \u00dccretsiz Dene\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-professional\">\u00dccretsiz deneme<\/span>\n                        <\/div>\n                        <h2>IVDR PEP ve PER \u00c7al\u0131\u015fma Alan\u0131<\/h2>\n                        <p class=\"kkdt-card-lead\">Bilimsel ge\u00e7erlilik, analitik performans ve klinik performans kan\u0131tlar\u0131n\u0131 IVDR Ek XIII yap\u0131s\u0131nda izlenebilir bir PEP\/PER \u00e7al\u0131\u015fma alan\u0131nda y\u00f6netin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Sekiz a\u015famal\u0131 \u00e7al\u0131\u015fma alan\u0131<\/li><li><span>\u2713<\/span>\u0130ddia\u2013kan\u0131t\u2013risk matrisi<\/li><li><span>\u2713<\/span>Eksiklik denetimi<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Performans De\u011ferlendirme Plan\u0131<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Performans De\u011ferlendirme Raporu<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz deneme<\/small><strong>\u00dccretsiz hesapla g\u00fcnl\u00fck 3 kullan\u0131m<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>IVDR<\/b><small>G\u00fcnde 3 \u00fccretsiz kullan\u0131m<\/small><\/span>\n                            <strong>\u00dccretsiz Dene <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-member\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/ivdr-urun-siniflandirma-kiti\/\"\n                             data-kkdt-card\n data-category=\"ivdr\"\n                             data-search=\"ivdr s\u0131n\u0131fland\u0131rma ivdr annex viii kurallar\u0131na g\u00f6re ivd s\u0131n\u0131f\u0131n\u0131 \u00f6n de\u011ferlendirin. ivdr ivdr ek viii kurallar\u0131na g\u00f6re cihaz\u0131n\u0131z\u0131n aday a, b, c veya d s\u0131n\u0131f\u0131n\u0131 \u00f6n de\u011ferlendirin. kullan\u0131m amac\u0131 ve risk etkisini de\u011ferlendirin uygulanabilir kural\u0131 g\u00f6r\u00fcn aday s\u0131n\u0131f\u0131 gerek\u00e7esiyle inceleyin ivdr \u00f6n s\u0131n\u0131fland\u0131rma sonucu\"\n                             aria-label=\"IVDR S\u0131n\u0131fland\u0131rma \u2014 \u00dccretsiz Hesap Olu\u015ftur\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"m12 3 9 5-9 5-9-5 9-5Z\"><\/path><path d=\"m3 12 9 5 9-5M3 16l9 5 9-5\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-member\">\u00dccretsiz \u00dcye<\/span>\n                        <\/div>\n                        <h2>IVDR S\u0131n\u0131fland\u0131rma<\/h2>\n                        <p class=\"kkdt-card-lead\">IVDR Ek VIII kurallar\u0131na g\u00f6re cihaz\u0131n\u0131z\u0131n aday A, B, C veya D s\u0131n\u0131f\u0131n\u0131 \u00f6n de\u011ferlendirin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Kullan\u0131m amac\u0131 ve risk etkisini de\u011ferlendirin<\/li><li><span>\u2713<\/span>Uygulanabilir kural\u0131 g\u00f6r\u00fcn<\/li><li><span>\u2713<\/span>Aday s\u0131n\u0131f\u0131 gerek\u00e7esiyle inceleyin<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>IVDR \u00f6n s\u0131n\u0131fland\u0131rma sonucu<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz \u00fcyelik<\/small><strong>Hesap olu\u015fturun ve \u00fccretsiz kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>IVDR<\/b><small>\u00dccretsiz \u00fcyelikle eri\u015fim<\/small><\/span>\n                            <strong>\u00dccretsiz Hesap Olu\u015ftur <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-member\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/ivdr-2017-746-onay-yolu-rehberi\/\"\n                             data-kkdt-card\n data-category=\"ivdr\"\n                             data-search=\"ivdr onay yolu class a, b, c ve d i\u00e7in uygunluk de\u011ferlendirme yap\u0131s\u0131n\u0131 inceleyin. ivdr ivd s\u0131n\u0131f\u0131na g\u00f6re uygunluk de\u011ferlendirme yap\u0131s\u0131n\u0131 ve onaylanm\u0131\u015f kurulu\u015f kat\u0131l\u0131m\u0131n\u0131 g\u00f6r\u00fcn. a\u2013d s\u0131n\u0131flar\u0131n\u0131 ayr\u0131 de\u011ferlendirin uygun onay yolunu g\u00f6r\u00fcnt\u00fcleyin temel belge ve g\u00f6zetim ad\u0131mlar\u0131n\u0131 anlay\u0131n ivdr onay yolu \u00f6zeti\"\n                             aria-label=\"IVDR Onay Yolu \u2014 \u00dccretsiz Hesap Olu\u015ftur\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><circle cx=\"6\" cy=\"18\" r=\"2\"><\/circle><circle cx=\"18\" cy=\"6\" r=\"2\"><\/circle><path d=\"M8 18h3a4 4 0 0 0 4-4v-4a2 2 0 0 1 2-2\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-member\">\u00dccretsiz \u00dcye<\/span>\n                        <\/div>\n                        <h2>IVDR Onay Yolu<\/h2>\n                        <p class=\"kkdt-card-lead\">IVD s\u0131n\u0131f\u0131na g\u00f6re uygunluk de\u011ferlendirme yap\u0131s\u0131n\u0131 ve onaylanm\u0131\u015f kurulu\u015f kat\u0131l\u0131m\u0131n\u0131 g\u00f6r\u00fcn.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>A\u2013D s\u0131n\u0131flar\u0131n\u0131 ayr\u0131 de\u011ferlendirin<\/li><li><span>\u2713<\/span>Uygun onay yolunu g\u00f6r\u00fcnt\u00fcleyin<\/li><li><span>\u2713<\/span>Temel belge ve g\u00f6zetim ad\u0131mlar\u0131n\u0131 anlay\u0131n<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>IVDR onay yolu \u00f6zeti<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz \u00fcyelik<\/small><strong>Hesap olu\u015fturun ve \u00fccretsiz kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>IVDR<\/b><small>\u00dccretsiz \u00fcyelikle eri\u015fim<\/small><\/span>\n                            <strong>\u00dccretsiz Hesap Olu\u015ftur <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-open is-public\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/hizlandirilmis-yaslandirma-hesaplama-araci\/\"\n                             data-kkdt-card\n data-category=\"mikrobiyoloji\"\n                             data-search=\"h\u0131zland\u0131r\u0131lm\u0131\u015f ya\u015fland\u0131rma q10 yakla\u015f\u0131m\u0131yla h\u0131zland\u0131r\u0131lm\u0131\u015f ya\u015fland\u0131rma s\u00fcresini ve takvimi hesaplay\u0131n. mikrobiyoloji q10 yakla\u015f\u0131m\u0131yla h\u0131zland\u0131r\u0131lm\u0131\u015f ya\u015fland\u0131rma s\u00fcresini ve hedef \u00e7al\u0131\u015fma tarihlerini hesaplay\u0131n. s\u0131cakl\u0131k ve q10 verilerini uygulay\u0131n h\u0131zland\u0131rma fakt\u00f6r\u00fcn\u00fc g\u00f6r\u00fcn ger\u00e7ek zaman e\u015fde\u011ferini planlay\u0131n ya\u015fland\u0131rma s\u00fcresi \u00c7al\u0131\u015fma takvimi\"\n                             aria-label=\"H\u0131zland\u0131r\u0131lm\u0131\u015f Ya\u015fland\u0131rma \u2014 Arac\u0131 A\u00e7\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><circle cx=\"12\" cy=\"12\" r=\"9\"><\/circle><path d=\"M12 7v5l3 2\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-public\">\u00dccretsiz<\/span>\n                        <\/div>\n                        <h2>H\u0131zland\u0131r\u0131lm\u0131\u015f Ya\u015fland\u0131rma<\/h2>\n                        <p class=\"kkdt-card-lead\">Q10 yakla\u015f\u0131m\u0131yla h\u0131zland\u0131r\u0131lm\u0131\u015f ya\u015fland\u0131rma s\u00fcresini ve hedef \u00e7al\u0131\u015fma tarihlerini hesaplay\u0131n.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>S\u0131cakl\u0131k ve Q10 verilerini uygulay\u0131n<\/li><li><span>\u2713<\/span>H\u0131zland\u0131rma fakt\u00f6r\u00fcn\u00fc g\u00f6r\u00fcn<\/li><li><span>\u2713<\/span>Ger\u00e7ek zaman e\u015fde\u011ferini planlay\u0131n<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Ya\u015fland\u0131rma s\u00fcresi<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>\u00c7al\u0131\u015fma takvimi<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-open\">\n                                <span aria-hidden=\"true\">\u2713<\/span>\n                                <div><small>Kullan\u0131ma haz\u0131r<\/small><strong>Kay\u0131t olmadan hemen kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>Mikrobiyoloji<\/b><small>Kay\u0131t gerektirmez<\/small><\/span>\n                            <strong>Arac\u0131 A\u00e7 <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-open is-public\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/koloni-sayisi-cfu-hesaplayici\/\"\n                             data-kkdt-card\n data-category=\"mikrobiyoloji\"\n                             data-search=\"cfu hesaplay\u0131c\u0131 koloni, seyreltme ve ekim hacmine g\u00f6re cfu sonucunu hesaplay\u0131n. mikrobiyoloji koloni say\u0131s\u0131, seyreltme oran\u0131 ve ekim hacmine g\u00f6re cfu sonucunu h\u0131zl\u0131 ve kontroll\u00fc hesaplay\u0131n. seyreltme fakt\u00f6r\u00fcn\u00fc uygulay\u0131n ekim hacmini hesaba kat\u0131n cfu\/ml veya cfu\/g sonucunu g\u00f6r\u00fcn cfu hesaplama sonucu\"\n                             aria-label=\"CFU Hesaplay\u0131c\u0131 \u2014 Arac\u0131 A\u00e7\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M14 6a4 4 0 0 0-5 5L3 17l4 4 6-6a4 4 0 0 0 5-5l-3 3-4-4 3-3Z\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-public\">\u00dccretsiz<\/span>\n                        <\/div>\n                        <h2>CFU Hesaplay\u0131c\u0131<\/h2>\n                        <p class=\"kkdt-card-lead\">Koloni say\u0131s\u0131, seyreltme oran\u0131 ve ekim hacmine g\u00f6re CFU sonucunu h\u0131zl\u0131 ve kontroll\u00fc hesaplay\u0131n.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Seyreltme fakt\u00f6r\u00fcn\u00fc uygulay\u0131n<\/li><li><span>\u2713<\/span>Ekim hacmini hesaba kat\u0131n<\/li><li><span>\u2713<\/span>CFU\/mL veya CFU\/g sonucunu g\u00f6r\u00fcn<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>CFU hesaplama sonucu<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-open\">\n                                <span aria-hidden=\"true\">\u2713<\/span>\n                                <div><small>Kullan\u0131ma haz\u0131r<\/small><strong>Kay\u0131t olmadan hemen kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>Mikrobiyoloji<\/b><small>Kay\u0131t gerektirmez<\/small><\/span>\n                            <strong>Arac\u0131 A\u00e7 <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-member\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/petri-goruntu-analiz-platformu\/\"\n                             data-kkdt-card\n data-category=\"mikrobiyoloji\"\n                             data-search=\"petri g\u00f6r\u00fcnt\u00fc analizi petri g\u00f6r\u00fcnt\u00fcs\u00fcndeki kolonileri otomatik i\u015faretleyin, manuel do\u011frulay\u0131n ve kay\u0131tl\u0131 say\u0131m raporu olu\u015fturun. mikrobiyoloji petri g\u00f6r\u00fcnt\u00fcs\u00fcndeki kolonileri otomatik belirleyin, manuel do\u011frulay\u0131n ve say\u0131m sonucunu raporlay\u0131n. kolonileri g\u00f6r\u00fcnt\u00fc \u00fczerinde i\u015faretleyin yanl\u0131\u015f i\u015faretleri manuel d\u00fczeltin cfu hesab\u0131yla sonucu tamamlay\u0131n \u0130\u015faretli petri g\u00f6r\u00fcnt\u00fcs\u00fc koloni say\u0131m \u00f6zeti\"\n                             aria-label=\"Petri G\u00f6r\u00fcnt\u00fc Analizi \u2014 \u00dccretsiz Hesap Olu\u015ftur\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M14 6a4 4 0 0 0-5 5L3 17l4 4 6-6a4 4 0 0 0 5-5l-3 3-4-4 3-3Z\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-member\">\u00dccretsiz \u00dcye<\/span>\n                        <\/div>\n                        <h2>Petri G\u00f6r\u00fcnt\u00fc Analizi<\/h2>\n                        <p class=\"kkdt-card-lead\">Petri g\u00f6r\u00fcnt\u00fcs\u00fcndeki kolonileri otomatik belirleyin, manuel do\u011frulay\u0131n ve say\u0131m sonucunu raporlay\u0131n.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Kolonileri g\u00f6r\u00fcnt\u00fc \u00fczerinde i\u015faretleyin<\/li><li><span>\u2713<\/span>Yanl\u0131\u015f i\u015faretleri manuel d\u00fczeltin<\/li><li><span>\u2713<\/span>CFU hesab\u0131yla sonucu tamamlay\u0131n<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>\u0130\u015faretli petri g\u00f6r\u00fcnt\u00fcs\u00fc<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Koloni say\u0131m \u00f6zeti<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz \u00fcyelik<\/small><strong>Hesap olu\u015fturun ve \u00fccretsiz kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>Mikrobiyoloji<\/b><small>\u00dccretsiz \u00fcyelikle eri\u015fim<\/small><\/span>\n                            <strong>\u00dccretsiz Hesap Olu\u015ftur <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-professional\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/biyolojik-yuk-sterilite-endotoksin-ve-test-sonuc-degerlendirme-araci\/\"\n                             data-kkdt-card\n data-category=\"mikrobiyoloji\"\n                             data-search=\"test sonu\u00e7 de\u011ferlendirme biyolojik y\u00fck, sterilite, endotoksin ve di\u011fer test sonu\u00e7lar\u0131n\u0131 de\u011ferlendirin. mikrobiyoloji biyolojik y\u00fck, sterilite ve endotoksin sonu\u00e7lar\u0131n\u0131 y\u00f6ntem, limit, seri ve sapma ba\u011flam\u0131yla birlikte de\u011ferlendirin. teste \u00f6zel i\u015f ak\u0131\u015f\u0131 limit ve seri de\u011ferlendirmesi sapma kayd\u0131 \u0130zlenebilir rapor test de\u011ferlendirme raporu limit kar\u015f\u0131la\u015ft\u0131rma \u00f6zeti ara\u015ft\u0131rma\/tekrar test notu\"\n                             aria-label=\"Test Sonu\u00e7 De\u011ferlendirme \u2014 \u00dccretsiz Dene\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M14 6a4 4 0 0 0-5 5L3 17l4 4 6-6a4 4 0 0 0 5-5l-3 3-4-4 3-3Z\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-professional\">\u00dccretsiz deneme<\/span>\n                        <\/div>\n                        <h2>Test Sonu\u00e7 De\u011ferlendirme<\/h2>\n                        <p class=\"kkdt-card-lead\">Biyolojik y\u00fck, sterilite ve endotoksin sonu\u00e7lar\u0131n\u0131 y\u00f6ntem, limit, seri ve sapma ba\u011flam\u0131yla birlikte de\u011ferlendirin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Teste \u00f6zel i\u015f ak\u0131\u015f\u0131<\/li><li><span>\u2713<\/span>Limit ve seri de\u011ferlendirmesi<\/li><li><span>\u2713<\/span>Sapma kayd\u0131<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Test de\u011ferlendirme raporu<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Limit kar\u015f\u0131la\u015ft\u0131rma \u00f6zeti<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz deneme<\/small><strong>\u00dccretsiz hesapla g\u00fcnl\u00fck 3 kullan\u0131m<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>Mikrobiyoloji<\/b><small>G\u00fcnde 3 \u00fccretsiz kullan\u0131m<\/small><\/span>\n                            <strong>\u00dccretsiz Dene <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-member\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/gmp-ve-mdr-numune-hesaplama-araci\/\"\n                             data-kkdt-card\n data-category=\"mikrobiyoloji\"\n                             data-search=\"gmp ve mdr numune hesaplama risk bazl\u0131 numune say\u0131s\u0131 ve numune noktas\u0131 plan\u0131n\u0131 olu\u015fturun. mikrobiyoloji lot b\u00fcy\u00fckl\u00fc\u011f\u00fc, risk ve g\u00fcven d\u00fczeyine g\u00f6re a\u00e7\u0131klanabilir bir numune alma plan\u0131 haz\u0131rlay\u0131n. \u0130statistiksel yakla\u015f\u0131m\u0131 se\u00e7in minimum numune say\u0131s\u0131n\u0131 hesaplay\u0131n temsil noktalar\u0131n\u0131 planlay\u0131n numune say\u0131s\u0131 temsil noktas\u0131 plan\u0131\"\n                             aria-label=\"GMP ve MDR Numune Hesaplama \u2014 \u00dccretsiz Hesap Olu\u015ftur\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M14 6a4 4 0 0 0-5 5L3 17l4 4 6-6a4 4 0 0 0 5-5l-3 3-4-4 3-3Z\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-member\">\u00dccretsiz \u00dcye<\/span>\n                        <\/div>\n                        <h2>GMP ve MDR Numune Hesaplama<\/h2>\n                        <p class=\"kkdt-card-lead\">Lot b\u00fcy\u00fckl\u00fc\u011f\u00fc, risk ve g\u00fcven d\u00fczeyine g\u00f6re a\u00e7\u0131klanabilir bir numune alma plan\u0131 haz\u0131rlay\u0131n.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>\u0130statistiksel yakla\u015f\u0131m\u0131 se\u00e7in<\/li><li><span>\u2713<\/span>Minimum numune say\u0131s\u0131n\u0131 hesaplay\u0131n<\/li><li><span>\u2713<\/span>Temsil noktalar\u0131n\u0131 planlay\u0131n<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Numune say\u0131s\u0131<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Temsil noktas\u0131 plan\u0131<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz \u00fcyelik<\/small><strong>Hesap olu\u015fturun ve \u00fccretsiz kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>Mikrobiyoloji<\/b><small>\u00dccretsiz \u00fcyelikle eri\u015fim<\/small><\/span>\n                            <strong>\u00dccretsiz Hesap Olu\u015ftur <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-professional\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/temizlik-validasyonu-ve-mikrobiyolojik-kontrol-degerlendirme-araci\/\"\n                             data-kkdt-card\n data-category=\"mikrobiyoloji\"\n                             data-search=\"temizlik validasyonu temizlik kan\u0131tlar\u0131n\u0131 ve mikrobiyolojik sonu\u00e7lar\u0131 raporlay\u0131n. mikrobiyoloji temizlik prosesinin kimyasal ve mikrobiyolojik kan\u0131tlar\u0131n\u0131 limit, numune noktas\u0131 ve seri baz\u0131nda de\u011ferlendirin. \u00dcr\u00fcn\/proses kapsam\u0131 limit de\u011ferlendirmesi seri ve nokta g\u00f6r\u00fcn\u00fcm\u00fc sapma ve capa notu validasyon sonu\u00e7 \u00f6zeti numune noktas\u0131 kar\u015f\u0131la\u015ft\u0131rmas\u0131 uygunluk ve sapma raporu\"\n                             aria-label=\"Temizlik Validasyonu \u2014 \u00dccretsiz Dene\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M14 6a4 4 0 0 0-5 5L3 17l4 4 6-6a4 4 0 0 0 5-5l-3 3-4-4 3-3Z\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-professional\">\u00dccretsiz deneme<\/span>\n                        <\/div>\n                        <h2>Temizlik Validasyonu<\/h2>\n                        <p class=\"kkdt-card-lead\">Temizlik prosesinin kimyasal ve mikrobiyolojik kan\u0131tlar\u0131n\u0131 limit, numune noktas\u0131 ve seri baz\u0131nda de\u011ferlendirin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>\u00dcr\u00fcn\/proses kapsam\u0131<\/li><li><span>\u2713<\/span>Limit de\u011ferlendirmesi<\/li><li><span>\u2713<\/span>Seri ve nokta g\u00f6r\u00fcn\u00fcm\u00fc<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Validasyon sonu\u00e7 \u00f6zeti<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Numune noktas\u0131 kar\u015f\u0131la\u015ft\u0131rmas\u0131<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz deneme<\/small><strong>\u00dccretsiz hesapla g\u00fcnl\u00fck 3 kullan\u0131m<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>Mikrobiyoloji<\/b><small>G\u00fcnde 3 \u00fccretsiz kullan\u0131m<\/small><\/span>\n                            <strong>\u00dccretsiz Dene <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-member\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/uts-kaydina-hazir-misiniz\/\"\n                             data-kkdt-card\n data-category=\"uts\"\n                             data-search=\"\u00dcts kay\u0131t haz\u0131rl\u0131\u011f\u0131 firma ve \u00fcr\u00fcn kayd\u0131 \u00f6ncesi haz\u0131rl\u0131k seviyenizi de\u011ferlendirin. \u00dcts \u00dcts firma ve \u00fcr\u00fcn kayd\u0131 \u00f6ncesinde belge, tan\u0131mlay\u0131c\u0131 ve sorumluluk haz\u0131rl\u0131\u011f\u0131n\u0131z\u0131 kontrol edin. firma kayd\u0131 \u00f6n ko\u015fullar\u0131n\u0131 g\u00f6zden ge\u00e7irin \u00dcr\u00fcn kay\u0131t belgelerini kontrol edin eksik haz\u0131rl\u0131klar\u0131 listeleyin \u00dcts haz\u0131rl\u0131k \u00f6zeti\"\n                             aria-label=\"\u00dcTS Kay\u0131t Haz\u0131rl\u0131\u011f\u0131 \u2014 \u00dccretsiz Hesap Olu\u015ftur\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M9 5h11M9 12h11M9 19h11M4 5l1 1 2-2M4 12l1 1 2-2M4 19l1 1 2-2\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-member\">\u00dccretsiz \u00dcye<\/span>\n                        <\/div>\n                        <h2>\u00dcTS Kay\u0131t Haz\u0131rl\u0131\u011f\u0131<\/h2>\n                        <p class=\"kkdt-card-lead\">\u00dcTS firma ve \u00fcr\u00fcn kayd\u0131 \u00f6ncesinde belge, tan\u0131mlay\u0131c\u0131 ve sorumluluk haz\u0131rl\u0131\u011f\u0131n\u0131z\u0131 kontrol edin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Firma kayd\u0131 \u00f6n ko\u015fullar\u0131n\u0131 g\u00f6zden ge\u00e7irin<\/li><li><span>\u2713<\/span>\u00dcr\u00fcn kay\u0131t belgelerini kontrol edin<\/li><li><span>\u2713<\/span>Eksik haz\u0131rl\u0131klar\u0131 listeleyin<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>\u00dcTS haz\u0131rl\u0131k \u00f6zeti<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz \u00fcyelik<\/small><strong>Hesap olu\u015fturun ve \u00fccretsiz kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>\u00dcTS<\/b><small>\u00dccretsiz \u00fcyelikle eri\u015fim<\/small><\/span>\n                            <strong>\u00dccretsiz Hesap Olu\u015ftur <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-member\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/uygunsuzluk-yakalama-oyunu\/\"\n                             data-kkdt-card\n data-category=\"egitim\"\n                             data-search=\"uygunsuzluk yakalama oyunu teknik dosya ve etiket hatalar\u0131n\u0131 senaryolar \u00fczerinden yakalay\u0131n. e\u011fitim etiket ve teknik dosya senaryolar\u0131ndaki uygunsuzluklar\u0131 uygulamal\u0131 \u00f6rneklerle yakalamay\u0131 deneyin. ger\u00e7ek\u00e7i senaryolar\u0131 inceleyin kritik hatalar\u0131 fark edin mevzuat bak\u0131\u015f\u0131n\u0131z\u0131 geli\u015ftirin senaryo de\u011ferlendirme sonucu\"\n                             aria-label=\"Uygunsuzluk Yakalama Oyunu \u2014 \u00dccretsiz Hesap Olu\u015ftur\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M14 6a4 4 0 0 0-5 5L3 17l4 4 6-6a4 4 0 0 0 5-5l-3 3-4-4 3-3Z\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-member\">\u00dccretsiz \u00dcye<\/span>\n                        <\/div>\n                        <h2>Uygunsuzluk Yakalama Oyunu<\/h2>\n                        <p class=\"kkdt-card-lead\">Etiket ve teknik dosya senaryolar\u0131ndaki uygunsuzluklar\u0131 uygulamal\u0131 \u00f6rneklerle yakalamay\u0131 deneyin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Ger\u00e7ek\u00e7i senaryolar\u0131 inceleyin<\/li><li><span>\u2713<\/span>Kritik hatalar\u0131 fark edin<\/li><li><span>\u2713<\/span>Mevzuat bak\u0131\u015f\u0131n\u0131z\u0131 geli\u015ftirin<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Senaryo de\u011ferlendirme sonucu<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz \u00fcyelik<\/small><strong>Hesap olu\u015fturun ve \u00fccretsiz kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>E\u011fitim<\/b><small>\u00dccretsiz \u00fcyelikle eri\u015fim<\/small><\/span>\n                            <strong>\u00dccretsiz Hesap Olu\u015ftur <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-open is-public\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/regulasyon-takvimi\/\"\n                             data-kkdt-card\n data-category=\"regulasyon\"\n                             data-search=\"reg\u00fclasyon takvimi mevzuat g\u00f6revlerini ve \u00f6nemli tarihleri tek merkezden takip edin. reg\u00fclasyon mevzuat tarihlerini, periyodik kalite g\u00f6revlerini, sorumlular\u0131 ve kan\u0131t kay\u0131tlar\u0131n\u0131 tek takvimde y\u00f6netin. resm\u00ee ve firma i\u00e7i tarihleri ay\u0131r\u0131n sorumlu ve kan\u0131t alanlar\u0131n\u0131 belirleyin yakla\u015fan g\u00f6revleri filtreleyin reg\u00fclasyon g\u00f6rev takvimi\"\n                             aria-label=\"Reg\u00fclasyon Takvimi \u2014 Arac\u0131 A\u00e7\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M14 6a4 4 0 0 0-5 5L3 17l4 4 6-6a4 4 0 0 0 5-5l-3 3-4-4 3-3Z\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-public\">\u00dccretsiz<\/span>\n                        <\/div>\n                        <h2>Reg\u00fclasyon Takvimi<\/h2>\n                        <p class=\"kkdt-card-lead\">Mevzuat tarihlerini, periyodik kalite g\u00f6revlerini, sorumlular\u0131 ve kan\u0131t kay\u0131tlar\u0131n\u0131 tek takvimde y\u00f6netin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Resm\u00ee ve firma i\u00e7i tarihleri ay\u0131r\u0131n<\/li><li><span>\u2713<\/span>Sorumlu ve kan\u0131t alanlar\u0131n\u0131 belirleyin<\/li><li><span>\u2713<\/span>Yakla\u015fan g\u00f6revleri filtreleyin<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Reg\u00fclasyon g\u00f6rev takvimi<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-open\">\n                                <span aria-hidden=\"true\">\u2713<\/span>\n                                <div><small>Kullan\u0131ma haz\u0131r<\/small><strong>Kay\u0131t olmadan hemen kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>Reg\u00fclasyon<\/b><small>Kay\u0131t gerektirmez<\/small><\/span>\n                            <strong>Arac\u0131 A\u00e7 <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-locked is-professional\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/dijital-araclar-giris\/?kkdt_return=https:\/\/www.kalitekit.com.tr\/en\/mtr-trend-raporu-olusturucu\/\"\n                             data-kkdt-card\n data-category=\"pms\"\n                             data-search=\"mtr trend raporu mdr\/ivdr pms verilerini \u00e7ok d\u00f6nemli analiz edin; oran oran\u0131, %95 g\u00fcven aral\u0131\u011f\u0131, grafik ve kontroll\u00fc mtr pdf olu\u015fturun. pms \u00c7ok d\u00f6nemli pms verilerini maruziyete g\u00f6re normalize edin; frekans, \u015fiddet ve istatistiksel sinyalleri mtr yap\u0131s\u0131nda raporlay\u0131n. \u00c7ok d\u00f6nemli veri analizi \u0130statistiksel sinyal grafik ve alt grup kayd\u0131 tam mtr \u00e7al\u0131\u015fma alan\u0131 manufacturer trend report tasla\u011f\u0131 d\u00f6nemsel trend grafi\u011fi \u0130statistik ve veri eki t\u00fcrk\u00e7e karakter destekli pdf\"\n                             aria-label=\"MTR Trend Raporu \u2014 \u00dccretsiz Dene\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><path d=\"M4 20V10M10 20V4M16 20v-7M22 20H2\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-professional\">\u00dccretsiz deneme<\/span>\n                        <\/div>\n                        <h2>MTR Trend Raporu<\/h2>\n                        <p class=\"kkdt-card-lead\">\u00c7ok d\u00f6nemli PMS verilerini maruziyete g\u00f6re normalize edin; frekans, \u015fiddet ve istatistiksel sinyalleri MTR yap\u0131s\u0131nda raporlay\u0131n.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>\u00c7ok d\u00f6nemli veri analizi<\/li><li><span>\u2713<\/span>\u0130statistiksel sinyal<\/li><li><span>\u2713<\/span>Grafik ve alt grup kayd\u0131<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Manufacturer Trend Report tasla\u011f\u0131<\/span>\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>D\u00f6nemsel trend grafi\u011fi<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-required\">\n                                <span aria-hidden=\"true\">\u2192<\/span>\n                                <div><small>\u00dccretsiz deneme<\/small><strong>\u00dccretsiz hesapla g\u00fcnl\u00fck 3 kullan\u0131m<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>PMS<\/b><small>G\u00fcnde 3 \u00fccretsiz kullan\u0131m<\/small><\/span>\n                            <strong>\u00dccretsiz Dene <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                                    <a class=\"kkdt-tool-card kkdt-catalog-card is-open is-public\"\n                             href=\"https:\/\/www.kalitekit.com.tr\/en\/sertifika-dogrulama\/\"\n                             data-kkdt-card\n data-category=\"dogrulama\"\n                             data-search=\"sertifika do\u011frulama kalitekit taraf\u0131ndan d\u00fczenlenen e\u011fitim belgelerini do\u011frulay\u0131n. do\u011frulama kalitekit e\u011fitim sertifikalar\u0131n\u0131 seri numaras\u0131 veya do\u011frulama bilgisiyle kontrol edin. belgenin ge\u00e7erlili\u011fini sorgulay\u0131n kat\u0131l\u0131mc\u0131 ve e\u011fitim bilgisini do\u011frulay\u0131n qr ba\u011flant\u0131s\u0131yla sonuca ula\u015f\u0131n sertifika do\u011frulama sonucu\"\n                             aria-label=\"Sertifika Do\u011frulama \u2014 Arac\u0131 A\u00e7\">\n                        <div class=\"kkdt-card-top kkdt-catalog-top\">\n                            <span class=\"kkdt-card-symbol\" aria-hidden=\"true\"><svg viewbox=\"0 0 24 24\"><circle cx=\"12\" cy=\"9\" r=\"6\"><\/circle><path d=\"m8 14-1 8 5-3 5 3-1-8\"><\/path><\/svg><\/span>\n                            <span class=\"kkdt-access kkdt-access-public\">\u00dccretsiz<\/span>\n                        <\/div>\n                        <h2>Sertifika Do\u011frulama<\/h2>\n                        <p class=\"kkdt-card-lead\">KaliteKit e\u011fitim sertifikalar\u0131n\u0131 seri numaras\u0131 veya do\u011frulama bilgisiyle kontrol edin.<\/p>\n                        <div class=\"kkdt-card-benefits\"><small>Bu ara\u00e7la<\/small><ul><li><span>\u2713<\/span>Belgenin ge\u00e7erlili\u011fini sorgulay\u0131n<\/li><li><span>\u2713<\/span>Kat\u0131l\u0131mc\u0131 ve e\u011fitim bilgisini do\u011frulay\u0131n<\/li><li><span>\u2713<\/span>QR ba\u011flant\u0131s\u0131yla sonuca ula\u015f\u0131n<\/li><\/ul><\/div>\n                                                    <div class=\"kkdt-card-output\">\n                                <small>Olu\u015fturabilece\u011finiz \u00e7\u0131kt\u0131<\/small>\n                                <div class=\"kkdt-output-tags\">\n                                                                            <span><svg viewbox=\"0 0 24 24\"><path d=\"M6 2h8l4 4v16H6z\"><\/path><path d=\"M14 2v5h5M9 12h6M9 16h6\"><\/path><\/svg>Sertifika do\u011frulama sonucu<\/span>\n                                                                    <\/div>\n                            <\/div>\n                                                                            <div class=\"kkdt-card-access-panel is-access-open\">\n                                <span aria-hidden=\"true\">\u2713<\/span>\n                                <div><small>Kullan\u0131ma haz\u0131r<\/small><strong>Kay\u0131t olmadan hemen kullan\u0131n<\/strong><\/div>\n                            <\/div>\n                                                <div class=\"kkdt-card-bottom kkdt-catalog-bottom\">\n                            <span><b>Do\u011frulama<\/b><small>Kay\u0131t gerektirmez<\/small><\/span>\n                            <strong>Arac\u0131 A\u00e7 <i>\u2192<\/i><\/strong>\n                        <\/div>\n                    <\/a>\n                            <\/div>\n            <p class=\"kkdt-empty\" hidden data-kkdt-empty>Araman\u0131zla e\u015fle\u015fen ara\u00e7 bulunamad\u0131.<\/p>\n        <\/section>\n        \n\n\n\n<section style=\"background:#f8faff; padding:50px 20px;\">\n  <div style=\"max-width:1050px; margin:0 auto;\">\n\n\n<div style=\"text-align:center; margin-bottom:35px;\">\n  <h1 style=\"font-size:34px; font-weight:700; color:#0b3c6f; margin-bottom:12px;\">\n    T\u0131bbi Cihaz Dok\u00fcman Kitleri ve Kalite Y\u00f6netim Paketleri\n  <\/h1>\n  <p style=\"font-size:18px; color:#555; line-height:1.7; max-width:850px; margin:0 auto;\">\n    KaliteKit dok\u00fcman kitleri; MDR, ISO 13485, GMP, \u00dcTS, EUDAMED, UDI, IVDR, risk analizi ve teknik dosya s\u00fcre\u00e7lerinde firmalar\u0131n daha sistematik haz\u0131rlanmas\u0131na yard\u0131mc\u0131 olmak amac\u0131yla geli\u015ftirilmi\u015ftir.\n  <\/p>\n<\/div>\n\n<div style=\"background:#ffffff; padding:32px; border-radius:14px; box-shadow:0 8px 25px rgba(0,0,0,0.05); margin-bottom:35px;\">\n  <h2 style=\"color:#0b3c6f; font-size:26px; font-weight:700; margin-bottom:16px;\">\n    T\u0131bbi cihaz dok\u00fcman kitleri ne i\u015fe yarar?\n  <\/h2>\n\n  <p style=\"color:#444; font-size:16px; line-height:1.8;\">\n    T\u0131bbi cihaz dok\u00fcman kitleri, \u00fcretici ve ithalat\u00e7\u0131 firmalar\u0131n kalite y\u00f6netim sistemi, teknik dosya, \u00fcr\u00fcn kay\u0131t, risk y\u00f6netimi, etiketleme, kullan\u0131m k\u0131lavuzu, uygunluk beyan\u0131 ve denetim haz\u0131rl\u0131\u011f\u0131 s\u00fcre\u00e7lerini daha kontroll\u00fc y\u00fcr\u00fctmesine destek olur. Bu kitler, firmalar\u0131n hangi dok\u00fcmana ihtiya\u00e7 duydu\u011funu anlamas\u0131na, eksik alanlar\u0131 g\u00f6rmesine ve s\u00fcreci daha planl\u0131 y\u00f6netmesine yard\u0131mc\u0131 olur.\n  <\/p>\n\n  <p style=\"color:#444; font-size:16px; line-height:1.8;\">\n    KaliteKit taraf\u0131ndan haz\u0131rlanan kitler; yaln\u0131zca bo\u015f form mant\u0131\u011f\u0131yla de\u011fil, uygulamada kullan\u0131labilecek yap\u0131, a\u00e7\u0131klama, kontrol listesi ve s\u00fcre\u00e7 rehberi yakla\u015f\u0131m\u0131yla haz\u0131rlan\u0131r. Her firman\u0131n \u00fcr\u00fcn grubu, risk s\u0131n\u0131f\u0131, faaliyet t\u00fcr\u00fc ve mevzuat y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fc farkl\u0131 oldu\u011fu i\u00e7in dok\u00fcman kitleri profesyonel dan\u0131\u015fmanl\u0131k yerine ge\u00e7mez; ancak haz\u0131rl\u0131k s\u00fcrecinde g\u00fc\u00e7l\u00fc bir ba\u015flang\u0131\u00e7 altyap\u0131s\u0131 sa\u011flar.\n  <\/p>\n<\/div>\n\n<div style=\"background:#ffffff; padding:32px; border-radius:14px; box-shadow:0 8px 25px rgba(0,0,0,0.05); margin-bottom:35px;\">\n  <h2 style=\"color:#0b3c6f; font-size:26px; font-weight:700; margin-bottom:16px;\">\n    Hangi alanlarda kit ve ara\u00e7lar sunuyoruz?\n  <\/h2>\n\n  <p style=\"color:#444; font-size:16px; line-height:1.8;\">\n    MDR kapsam\u0131nda teknik dosya haz\u0131rl\u0131\u011f\u0131 yapan firmalar i\u00e7in <a href=\"https:\/\/www.kalitekit.com.tr\/en\/mdr-teknik-dosya-kontrol-kit\/\">MDR teknik dosya kontrol kiti<\/a>, GSPR, risk y\u00f6netimi, etiket, kullan\u0131m k\u0131lavuzu, klinik de\u011ferlendirme, PMS\/PMCF ve uygunluk beyan\u0131 gibi ba\u015fl\u0131klar\u0131n \u00f6n de\u011ferlendirilmesine yard\u0131mc\u0131 olur.\n  <\/p>\n\n  <p style=\"color:#444; font-size:16px; line-height:1.8;\">\n    Risk y\u00f6netimi s\u00fcrecinde <a href=\"https:\/\/www.kalitekit.com.tr\/en\/iso-14971-risk-analiz-kiti\/\">ISO 14971 risk analiz kiti<\/a>, tehlike tan\u0131mlama, risk kontrol\u00fc, art\u0131k risk de\u011ferlendirmesi ve risk-fayda yakla\u015f\u0131m\u0131n\u0131n daha sistematik ele al\u0131nmas\u0131na destek olur. Bu s\u00fcre\u00e7, MDR teknik dosya ve ISO 13485 kalite y\u00f6netim sistemiyle birlikte de\u011ferlendirilmelidir.\n  <\/p>\n\n  <p style=\"color:#444; font-size:16px; line-height:1.8;\">\n    \u00dcr\u00fcn kay\u0131t ve veri haz\u0131rl\u0131\u011f\u0131 s\u00fcre\u00e7lerinde <a href=\"https:\/\/www.kalitekit.com.tr\/en\/eudamed-kayit-danismanligi\/\">EUDAMED kay\u0131t dan\u0131\u015fmanl\u0131\u011f\u0131<\/a>, <a href=\"https:\/\/www.kalitekit.com.tr\/en\/eudamed-toplu-urun-kaydi-ve-xml-hazirlama-hizmeti\/\">EUDAMED toplu \u00fcr\u00fcn kayd\u0131 ve XML haz\u0131rlama hizmeti<\/a>, <a href=\"https:\/\/www.kalitekit.com.tr\/en\/udi-di-ve-udi-pi-olusturma-rehberi-tum-adimlar-ve-ornekler\/\">UDI-DI ve UDI-PI rehberi<\/a> ve <a href=\"https:\/\/www.kalitekit.com.tr\/en\/emdn-kod-arama-kiti\/\">EMDN kod arama kiti<\/a> birlikte kullan\u0131labilir.\n  <\/p>\n\n  <p style=\"color:#444; font-size:16px; line-height:1.8;\">\n    Kalite y\u00f6netim sistemi taraf\u0131nda <a href=\"https:\/\/www.kalitekit.com.tr\/en\/iso-13485-danismanligi\/\">ISO 13485 dan\u0131\u015fmanl\u0131\u011f\u0131<\/a>, prosed\u00fcr, kay\u0131t, s\u00fcre\u00e7 y\u00f6netimi, i\u00e7 tetkik, tedarik\u00e7i de\u011ferlendirme ve belgelendirme haz\u0131rl\u0131\u011f\u0131 ba\u015fl\u0131klar\u0131n\u0131 kapsar. \u00dcretim s\u00fcre\u00e7leri i\u00e7in <a href=\"https:\/\/www.kalitekit.com.tr\/en\/gmp-iyi-uretim-uygulamalari-danismanligi\/\">GMP dan\u0131\u015fmanl\u0131\u011f\u0131<\/a>, hijyen, validasyon, izlenebilirlik ve proses disiplini a\u00e7\u0131s\u0131ndan firmalara destek sa\u011flar.\n  <\/p>\n<\/div>\n\n<div style=\"background:#ffffff; padding:32px; border-radius:14px; box-shadow:0 8px 25px rgba(0,0,0,0.05); margin-bottom:35px;\">\n  <h2 style=\"color:#0b3c6f; font-size:26px; font-weight:700; margin-bottom:16px;\">\n    Hesaplama ara\u00e7lar\u0131 ve pratik kalite kitleri\n  <\/h2>\n\n  <p style=\"color:#444; font-size:16px; line-height:1.8;\">\n    KaliteKit \u00fczerinde yer alan <a href=\"https:\/\/www.kalitekit.com.tr\/en\/kalite-yonetim-araclari\/\">kalite y\u00f6netim ara\u00e7lar\u0131<\/a>, firmalar\u0131n teknik dosya, kalite kontrol, validasyon ve \u00fcr\u00fcn kay\u0131t s\u00fcre\u00e7lerinde \u00f6n de\u011ferlendirme yapmas\u0131na yard\u0131mc\u0131 olur. Bu ara\u00e7lar, dok\u00fcman kitleriyle birlikte kullan\u0131ld\u0131\u011f\u0131nda daha b\u00fct\u00fcnc\u00fcl bir haz\u0131rl\u0131k yap\u0131s\u0131 olu\u015fturur.\n  <\/p>\n\n  <p style=\"color:#444; font-size:16px; line-height:1.8;\">\n    Mikrobiyoloji ve kalite kontrol s\u00fcre\u00e7leri i\u00e7in <a href=\"https:\/\/www.kalitekit.com.tr\/en\/koloni-sayisi-cfu-hesaplayici\/\">CFU hesaplay\u0131c\u0131<\/a>, validasyon planlamas\u0131 i\u00e7in <a href=\"https:\/\/www.kalitekit.com.tr\/en\/gmp-ve-mdr-numune-hesaplama-araci\/\">numune say\u0131s\u0131 hesaplama arac\u0131<\/a>, raf \u00f6mr\u00fc ve ambalaj validasyonu i\u00e7in ise <a href=\"https:\/\/www.kalitekit.com.tr\/en\/hizlandirilmis-yaslandirma-hesaplama-araci\/\">h\u0131zland\u0131r\u0131lm\u0131\u015f ya\u015fland\u0131rma hesaplama arac\u0131<\/a> kullan\u0131labilir.\n  <\/p>\n<\/div>\n\n<div style=\"background:#eef6ff; padding:30px; border-radius:14px; margin-bottom:35px;\">\n  <h2 style=\"color:#0b3c6f; font-size:25px; font-weight:700; margin-bottom:14px;\">\n    Kitleri kullan\u0131rken dikkat edilmesi gerekenler\n  <\/h2>\n\n  <ul style=\"color:#444; font-size:16px; line-height:1.9; padding-left:20px; margin:0;\">\n    <li>Her kit, firman\u0131n \u00fcr\u00fcn grubu ve faaliyet kapsam\u0131na g\u00f6re uyarlanmal\u0131d\u0131r.<\/li>\n    <li>MDR, IVDR, ISO 13485, \u00dcTS ve EUDAMED s\u00fcre\u00e7leri birbirinden ba\u011f\u0131ms\u0131z d\u00fc\u015f\u00fcn\u00fclmemelidir.<\/li>\n    <li>Dok\u00fcmanlar yaln\u0131zca dosya olu\u015fturmak i\u00e7in de\u011fil, ger\u00e7ek s\u00fcre\u00e7leri desteklemek i\u00e7in kullan\u0131lmal\u0131d\u0131r.<\/li>\n    <li>Risk s\u0131n\u0131f\u0131, kullan\u0131m amac\u0131, \u00fcr\u00fcn varyantlar\u0131 ve kay\u0131t gereklilikleri ayr\u0131ca de\u011ferlendirilmelidir.<\/li>\n    <li>Denetim veya belgelendirme \u00f6ncesinde profesyonel uygunluk kontrol\u00fc yap\u0131lmas\u0131 \u00f6nerilir.<\/li>\n  <\/ul>\n<\/div>\n\n<div style=\"text-align:center; color:#666; font-size:14px; line-height:1.7; margin-bottom:30px;\">\n  <p>\n    <strong>Not:<\/strong> Bu sayfada yer alan kitler, ara\u00e7lar ve a\u00e7\u0131klamalar bilgilendirme ve haz\u0131rl\u0131k amac\u0131yla sunulmu\u015ftur. Nihai mevzuat uygunlu\u011fu; \u00fcr\u00fcn kapsam\u0131, teknik dosya, kalite sistemi, risk s\u0131n\u0131f\u0131 ve ilgili yasal gereklilikler birlikte de\u011ferlendirilerek belirlenmelidir.\n  <\/p>\n<\/div>\n\n<div style=\"text-align:center;\">\n  <a href=\"https:\/\/www.kalitekit.com.tr\/en\/iletisim\/\" style=\"background:#0b3c6f; color:#ffffff; padding:16px 34px; font-size:18px; border-radius:8px; text-decoration:none; display:inline-block; font-weight:600;\">\n    Kitler Hakk\u0131nda Destek Al\n  <\/a>\n<\/div>\n\n\n  <\/div>\n<\/section>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>T\u0131bbi Cihaz Dok\u00fcman Kitleri ve Kalite Y\u00f6netim Paketleri KaliteKit dok\u00fcman kitleri; MDR, ISO 13485, GMP, \u00dcTS, EUDAMED, UDI, IVDR, risk [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"","ast-site-content-layout":"normal-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-9007","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/pages\/9007","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=9007"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/pages\/9007\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=9007"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}