{"id":10277,"date":"2026-01-02T12:52:59","date_gmt":"2026-01-02T12:52:59","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=10277"},"modified":"2026-06-04T08:09:51","modified_gmt":"2026-06-04T08:09:51","slug":"sahadan-notlar-mdr-denetimlerinde-en-sik-sorulan-sorular-ve-arkasindaki-gercek-beklenti","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/sahadan-notlar-mdr-denetimlerinde-en-sik-sorulan-sorular-ve-arkasindaki-gercek-beklenti\/","title":{"rendered":"Sahadan Notlar: MDR Denetimlerinde En S\u0131k Sorulan Sorular ve Arkas\u0131ndaki Ger\u00e7ek Beklenti"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10277\" class=\"elementor elementor-10277\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-13d5a339 e-flex e-con-boxed e-con e-parent\" data-id=\"13d5a339\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div 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{\n      padding: 16px 18px;\n      color: var(--kk-text);\n    }\n\n    .kk-mdr-cta {\n      background:\n        linear-gradient(135deg, rgba(11,60,111,0.97), rgba(16,32,51,0.96)),\n        radial-gradient(circle at right top, rgba(25,167,206,0.34), transparent 38%);\n      color: #fff;\n      border-radius: var(--kk-radius-xl);\n      padding: clamp(26px, 5vw, 44px);\n      margin-top: 24px;\n      box-shadow: var(--kk-shadow);\n    }\n\n    .kk-mdr-cta h2 {\n      color: #fff;\n      margin: 0 0 12px;\n      font-size: clamp(26px, 4vw, 40px);\n      line-height: 1.15;\n    }\n\n    .kk-mdr-cta p {\n      color: rgba(255,255,255,0.88);\n      max-width: 820px;\n      margin-bottom: 22px;\n    }\n\n    .kk-mdr-note {\n      color: var(--kk-muted) !important;\n      font-size: 13px !important;\n      margin-top: 14px !important;\n    }\n\n    .kk-mdr-link {\n      color: var(--kk-primary) !important;\n      font-weight: 900;\n      text-decoration: underline;\n      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padding: 16px;\n      }\n\n      .kk-mdr-question-head {\n        gap: 10px;\n      }\n\n      .kk-mdr-number {\n        flex-basis: 34px;\n        width: 34px;\n        height: 34px;\n      }\n\n      .kk-mdr-table th,\n      .kk-mdr-table td {\n        padding: 12px;\n      }\n    }\n  <\/style>\n\n  <div class=\"kk-mdr-container\">\n    <header class=\"kk-mdr-hero\">\n      <div class=\"kk-mdr-eyebrow\">KaliteKit \u2022 MDR Denetim Haz\u0131rl\u0131\u011f\u0131<\/div>\n      <h1>MDR denetimlerinde en s\u0131k sorulan sorular ve denet\u00e7inin ger\u00e7ekten arad\u0131\u011f\u0131 cevaplar<\/h1>\n      <p>\n        MDR denetimlerinde kritik olan yaln\u0131zca \u201changi soru gelecek?\u201d de\u011fildir. As\u0131l mesele; teknik dosya, GSPR, risk y\u00f6netimi, klinik de\u011ferlendirme, etiket\/IFU, UDI ve PMS kay\u0131tlar\u0131n\u0131n birbirini destekleyen ya\u015fayan bir sistem olarak \u00e7al\u0131\u015f\u0131p \u00e7al\u0131\u015fmad\u0131\u011f\u0131d\u0131r.\n      <\/p>\n      <div class=\"kk-mdr-hero-actions\">\n        <a class=\"kk-mdr-btn kk-mdr-btn-primary\" href=\"#kk-mdr-kontrol-listesi\">Denetim kontrol listesine git<\/a>\n        <a class=\"kk-mdr-btn kk-mdr-btn-secondary\" href=\"https:\/\/www.kalitekit.com.tr\/iletisim\/\">\u00d6n de\u011ferlendirme talep et<\/a>\n      <\/div>\n    <\/header>\n\n    <div class=\"kk-mdr-stat-grid\" aria-label=\"MDR denetim odak alanlar\u0131\">\n      <div class=\"kk-mdr-stat\"><strong>Ek II<\/strong><span>Teknik dok\u00fcmantasyon yap\u0131s\u0131<\/span><\/div>\n      <div class=\"kk-mdr-stat\"><strong>Ek III<\/strong><span>Piyasa sonras\u0131 g\u00f6zetim<\/span><\/div>\n      <div class=\"kk-mdr-stat\"><strong>Ek I<\/strong><span>GSPR ve kan\u0131t e\u015fle\u015ftirme<\/span><\/div>\n      <div class=\"kk-mdr-stat\"><strong>ISO 14971<\/strong><span>Risk y\u00f6netimi ba\u011flant\u0131s\u0131<\/span><\/div>\n    <\/div>\n\n    <div class=\"kk-mdr-layout\">\n      <main class=\"kk-mdr-main\">\n        <section class=\"kk-mdr-section\">\n          <h2>Denetimde do\u011fru yakla\u015f\u0131m: soru ezberlemek de\u011fil, sistem g\u00f6stermek<\/h2>\n          <p class=\"kk-mdr-lead\">\n            MDR denetimlerine giren firmalarda en s\u0131k duyulan c\u00fcmle \u015fudur: <strong>\u201cDenetimde ne soracaklar?\u201d<\/strong> Bu soru anla\u015f\u0131l\u0131rd\u0131r; ancak denet\u00e7inin bak\u0131\u015f a\u00e7\u0131s\u0131n\u0131 tam kar\u015f\u0131lamaz.\n          <\/p>\n          <div class=\"kk-mdr-highlight\">\n            <strong>Do\u011fru soru \u015fudur:<\/strong><br>\n            \u201cDenet\u00e7i bu soruyla hangi kan\u0131t\u0131, hangi ba\u011flant\u0131y\u0131 ve hangi sistem olgunlu\u011funu g\u00f6rmek istiyor?\u201d\n          <\/div>\n          <p>\n            \u00c7\u00fcnk\u00fc MDR denetimi bir belge kontrol\u00fcnden ibaret de\u011fildir. Denet\u00e7i; \u00fcr\u00fcn\u00fcn kullan\u0131m amac\u0131, s\u0131n\u0131fland\u0131rmas\u0131, teknik dosyas\u0131, GSPR kan\u0131tlar\u0131, risk kontrolleri, klinik de\u011ferlendirmesi, PMS \u00e7\u0131kt\u0131lar\u0131 ve etiket\/IFU iddialar\u0131 aras\u0131nda tutarl\u0131 bir izlenebilirlik g\u00f6rmek ister.\n          <\/p>\n        <\/section>\n\n        <section class=\"kk-mdr-section\">\n          <h2>Denet\u00e7inin ilk bakt\u0131\u011f\u0131 zincir: teknik dosya \u2192 risk \u2192 klinik \u2192 PMS<\/h2>\n          <p>\n            Teknik dosya yaln\u0131zca klas\u00f6re konmu\u015f belgelerden olu\u015fmaz. MDR mant\u0131\u011f\u0131nda teknik dosya; cihaz\u0131n g\u00fcvenli, performansl\u0131 ve uygun oldu\u011funu kan\u0131tlayan izlenebilir bir yap\u0131d\u0131r. Bu nedenle denetimde belgeler tek tek de\u011fil, birbirleriyle ba\u011flant\u0131l\u0131 \u015fekilde de\u011ferlendirilir.\n          <\/p>\n\n          <div class=\"kk-mdr-process\" aria-label=\"MDR denetim ba\u011flant\u0131 ak\u0131\u015f\u0131\">\n            <div class=\"kk-mdr-step\">\n              <span>1<\/span>\n              <h3>Cihaz tan\u0131m\u0131<\/h3>\n              <p>Kullan\u0131m amac\u0131, kullan\u0131c\u0131 profili, varyantlar, aksesuarlar ve \u00fcr\u00fcn ailesi netle\u015fir.<\/p>\n            <\/div>\n            <div class=\"kk-mdr-step\">\n              <span>2<\/span>\n              <h3>Risk ve GSPR<\/h3>\n              <p>Tehlikeler, risk kontrol \u00f6nlemleri ve GSPR kan\u0131tlar\u0131 ayn\u0131 mant\u0131\u011fa ba\u011flan\u0131r.<\/p>\n            <\/div>\n            <div class=\"kk-mdr-step\">\n              <span>3<\/span>\n              <h3>Klinik kan\u0131t<\/h3>\n              <p>Performans iddialar\u0131, literat\u00fcr, klinik veri ve PMCF gerek\u00e7esiyle desteklenir.<\/p>\n            <\/div>\n            <div class=\"kk-mdr-step\">\n              <span>4<\/span>\n              <h3>PMS geri besleme<\/h3>\n              <p>\u015eikayet, trend, vigilans ve saha verileri risk ve klinik dosyaya geri d\u00f6ner.<\/p>\n            <\/div>\n          <\/div>\n\n          <p class=\"kk-mdr-note\">\n            Not: Class I cihazlarda da teknik dok\u00fcmantasyon ve PMS dosyas\u0131n\u0131n MDR Ek II\/Ek III yakla\u015f\u0131m\u0131na g\u00f6re haz\u0131rlanmas\u0131 beklenir. Standart Class I cihazlarda notified body olmayabilir; ancak bu durum teknik dosya, risk y\u00f6netimi, klinik de\u011ferlendirme ve PMS y\u00fck\u00fcml\u00fcl\u00fcklerini ortadan kald\u0131rmaz.\n          <\/p>\n        <\/section>\n\n        <section class=\"kk-mdr-section\">\n          <h2>MDR denetimlerinde en s\u0131k gelen 8 soru<\/h2>\n          <p>\n            A\u015fa\u011f\u0131daki sorular yaln\u0131zca \u201ccevap verilecek sorular\u201d de\u011fildir. Her biri, denet\u00e7inin sisteminizde g\u00f6rmek istedi\u011fi bir kan\u0131t ba\u011flant\u0131s\u0131n\u0131 temsil eder.\n          <\/p>\n\n          <div class=\"kk-mdr-question-list\">\n            <article class=\"kk-mdr-question-card\">\n              <div class=\"kk-mdr-question-head\">\n                <span class=\"kk-mdr-number\">1<\/span>\n                <div>\n                  <h3>\u201cBu cihaz i\u00e7in MDR kapsam\u0131ndaki rol\u00fcn\u00fcz nedir?\u201d<\/h3>\n                  <p>\u00dcretici, yetkili temsilci, ithalat\u00e7\u0131 veya da\u011f\u0131t\u0131c\u0131 rol\u00fc net de\u011filse sorumluluk zinciri de belirsiz hale gelir.<\/p>\n                <\/div>\n              <\/div>\n              <ul>\n                <li>Ekonomik operat\u00f6r rol\u00fc prosed\u00fcrlerde ve s\u00f6zle\u015fmelerde tan\u0131ml\u0131 m\u0131?<\/li>\n                <li>Teknik dosya, PMS, vigilans ve kay\u0131t s\u00fcre\u00e7lerinde kimin ne yapt\u0131\u011f\u0131 belli mi?<\/li>\n                <li>PRRC\/sorumlu ki\u015fi ve proses sahipleri atanm\u0131\u015f m\u0131?<\/li>\n              <\/ul>\n              <div class=\"kk-mdr-auditor-intent\"><strong>Denet\u00e7inin amac\u0131:<\/strong> Firma rol\u00fcn\u00fc biliyor mu, yasal sorumlulu\u011fu sahipleniyor mu, s\u00fcre\u00e7 ki\u015filere ve kay\u0131tlara atanm\u0131\u015f m\u0131?<\/div>\n            <\/article>\n\n            <article class=\"kk-mdr-question-card\">\n              <div class=\"kk-mdr-question-head\">\n                <span class=\"kk-mdr-number\">2<\/span>\n                <div>\n                  <h3>\u201cCihaz\u0131n kullan\u0131m amac\u0131 ve s\u0131n\u0131fland\u0131rma gerek\u00e7esi t\u00fcm dok\u00fcmanlarda ayn\u0131 m\u0131?\u201d<\/h3>\n                  <p>Denet\u00e7i, kullan\u0131m amac\u0131n\u0131n teknik dosya, etiket, IFU, klinik de\u011ferlendirme ve uygunluk beyan\u0131nda ayn\u0131 anlat\u0131l\u0131p anlat\u0131lmad\u0131\u011f\u0131n\u0131 kontrol eder.<\/p>\n                <\/div>\n              <\/div>\n              <ul>\n                <li>Kullan\u0131m amac\u0131 \u00fcr\u00fcn iddialar\u0131yla uyumlu mu?<\/li>\n                <li>Risk s\u0131n\u0131f\u0131 MDR Ek VIII kural\u0131na g\u00f6re gerek\u00e7elendirilmi\u015f mi?<\/li>\n                <li>Class I \/ Is \/ Im \/ Ir ayr\u0131m\u0131 do\u011fru yap\u0131lm\u0131\u015f m\u0131?<\/li>\n              <\/ul>\n              <div class=\"kk-mdr-auditor-intent\"><strong>Denet\u00e7inin amac\u0131:<\/strong> Cihaz\u0131n kapsam\u0131 kaygan m\u0131, \u00fcr\u00fcn iddialar\u0131 s\u0131n\u0131f\u0131 de\u011fi\u015ftiriyor mu, uygunluk yolu do\u011fru mu?<\/div>\n            <\/article>\n\n            <article class=\"kk-mdr-question-card\">\n              <div class=\"kk-mdr-question-head\">\n                <span class=\"kk-mdr-number\">3<\/span>\n                <div>\n                  <h3>\u201cGSPR tablosunda her uygulanabilir gereklilik i\u00e7in ger\u00e7ek kan\u0131t var m\u0131?\u201d<\/h3>\n                  <p>GSPR tablosu sadece \u201cuygundur\u201d yaz\u0131lan bir liste de\u011fildir. Her gereklilik; test, analiz, prosed\u00fcr, rapor veya gerek\u00e7eyle desteklenmelidir.<\/p>\n                <\/div>\n              <\/div>\n              <ul>\n                <li>Uygulanabilir \/ uygulanamaz kararlar\u0131 gerek\u00e7eli mi?<\/li>\n                <li>Kan\u0131t dok\u00fcman kodu, revizyonu ve tarihi yaz\u0131lm\u0131\u015f m\u0131?<\/li>\n                <li>GSPR sat\u0131rlar\u0131 risk y\u00f6netimi, klinik de\u011ferlendirme ve test raporlar\u0131yla ba\u011fl\u0131 m\u0131?<\/li>\n              <\/ul>\n              <div class=\"kk-mdr-auditor-intent\"><strong>Denet\u00e7inin amac\u0131:<\/strong> Firma GSPR\u2019yi tablo olarak m\u0131 doldurmu\u015f, yoksa cihaz uygunlu\u011funu kan\u0131tlayan bir izlenebilirlik matrisi olarak m\u0131 kullan\u0131yor?<\/div>\n            <\/article>\n\n            <article class=\"kk-mdr-question-card\">\n              <div class=\"kk-mdr-question-head\">\n                <span class=\"kk-mdr-number\">4<\/span>\n                <div>\n                  <h3>\u201cRisk y\u00f6netimi dosyan\u0131z en son ne zaman g\u00fcncellendi?\u201d<\/h3>\n                  <p>Risk dosyas\u0131, \u00fcr\u00fcn piyasaya \u00e7\u0131kt\u0131ktan sonra da ya\u015fayan bir kay\u0131tt\u0131r. \u015eikayet, CAPA, PMS, trend ve tasar\u0131m de\u011fi\u015fikli\u011fi risk dosyas\u0131n\u0131 etkileyebilir.<\/p>\n                <\/div>\n              <\/div>\n              <ul>\n                <li>Tehlikeler ve zarar senaryolar\u0131 \u00fcr\u00fcne \u00f6zg\u00fc m\u00fc?<\/li>\n                <li>Risk kontrol \u00f6nlemleri IFU, etiket, tasar\u0131m veya proses kontrol\u00fcne yans\u0131m\u0131\u015f m\u0131?<\/li>\n                <li>Art\u0131k risk kabul kriterleri y\u00f6netim taraf\u0131ndan tan\u0131mlanm\u0131\u015f m\u0131?<\/li>\n              <\/ul>\n              <div class=\"kk-mdr-auditor-intent\"><strong>Denet\u00e7inin amac\u0131:<\/strong> Risk y\u00f6netimi tek seferlik tablo mu, yoksa PMS ve de\u011fi\u015fiklik y\u00f6netimiyle beslenen aktif bir s\u00fcre\u00e7 mi?<\/div>\n            <\/article>\n\n            <article class=\"kk-mdr-question-card\">\n              <div class=\"kk-mdr-question-head\">\n                <span class=\"kk-mdr-number\">5<\/span>\n                <div>\n                  <h3>\u201cKlinik de\u011ferlendirmenizi nas\u0131l g\u00fcncel tutuyorsunuz?\u201d<\/h3>\n                  <p>MDR denetiminde klinik de\u011ferlendirme, yaln\u0131zca haz\u0131rlanm\u0131\u015f bir CER dok\u00fcman\u0131 olarak g\u00f6r\u00fclmez. Denet\u00e7i, klinik verinin g\u00fcncelli\u011fini ve PMS ile ba\u011flant\u0131s\u0131n\u0131 sorgular.<\/p>\n                <\/div>\n              <\/div>\n              <ul>\n                <li>Literat\u00fcr tarama stratejisi, veri tabanlar\u0131 ve tarih aral\u0131\u011f\u0131 tan\u0131ml\u0131 m\u0131?<\/li>\n                <li>E\u015fde\u011ferlik iddias\u0131 varsa teknik, biyolojik ve klinik gerek\u00e7eler yeterli mi?<\/li>\n                <li>PMCF gerekli de\u011filse gerek\u00e7e \u00fcr\u00fcn risk profiline g\u00f6re savunulabilir mi?<\/li>\n              <\/ul>\n              <div class=\"kk-mdr-auditor-intent\"><strong>Denet\u00e7inin amac\u0131:<\/strong> Klinik de\u011ferlendirme ya\u015fayan bir s\u00fcre\u00e7 mi, yoksa denetim \u00f6ncesi haz\u0131rlanm\u0131\u015f statik bir rapor mu?<\/div>\n            <\/article>\n\n            <article class=\"kk-mdr-question-card\">\n              <div class=\"kk-mdr-question-head\">\n                <span class=\"kk-mdr-number\">6<\/span>\n                <div>\n                  <h3>\u201cPMS verilerini nas\u0131l topluyor, de\u011ferlendiriyor ve aksiyona d\u00f6n\u00fc\u015ft\u00fcr\u00fcyorsunuz?\u201d<\/h3>\n                  <p>PMS plan\u0131 varsa ancak veri analizi yap\u0131lm\u0131yorsa sistem eksik kabul edilir. PMS \u00e7\u0131kt\u0131lar\u0131; risk dosyas\u0131n\u0131, klinik de\u011ferlendirmeyi, IFU\/etiketi ve CAPA\u2019y\u0131 tetiklemelidir.<\/p>\n                <\/div>\n              <\/div>\n              <ul>\n                <li>\u015eikayet, m\u00fc\u015fteri geri bildirimi, servis kayd\u0131, literat\u00fcr ve sat\u0131\u015f sonras\u0131 veriler tan\u0131ml\u0131 m\u0131?<\/li>\n                <li>Trend e\u015fikleri ve de\u011ferlendirme s\u0131kl\u0131\u011f\u0131 belirlenmi\u015f mi?<\/li>\n                <li>PMS raporu \/ PSUR \u00e7\u0131kt\u0131lar\u0131 ilgili s\u00fcre\u00e7lere geri besleniyor mu?<\/li>\n              <\/ul>\n              <div class=\"kk-mdr-auditor-intent\"><strong>Denet\u00e7inin amac\u0131:<\/strong> Firma piyasadaki \u00fcr\u00fcn\u00fcn\u00fc aktif izliyor mu, saha verisini karar mekanizmas\u0131na dahil ediyor mu?<\/div>\n            <\/article>\n\n            <article class=\"kk-mdr-question-card\">\n              <div class=\"kk-mdr-question-head\">\n                <span class=\"kk-mdr-number\">7<\/span>\n                <div>\n                  <h3>\u201cEtiket, IFU ve UDI bilgileriniz teknik dosyayla tutarl\u0131 m\u0131?\u201d<\/h3>\n                  <p>Etiket ve kullan\u0131m k\u0131lavuzu, teknik dosyan\u0131n sahaya yans\u0131yan y\u00fcz\u00fcd\u00fcr. Yanl\u0131\u015f sembol, eksik uyar\u0131 veya tutars\u0131z kullan\u0131m amac\u0131 denetimde h\u0131zl\u0131ca fark edilir.<\/p>\n                <\/div>\n              <\/div>\n              <ul>\n                <li>ISO 15223-1 sembolleri do\u011fru ve a\u00e7\u0131klanabilir \u015fekilde kullan\u0131lm\u0131\u015f m\u0131?<\/li>\n                <li>IFU\u2019daki uyar\u0131lar risk kontrol \u00f6nlemleriyle ba\u011flant\u0131l\u0131 m\u0131?<\/li>\n                <li>UDI-DI, Basic UDI-DI, model\/varyant ve ambalaj seviyesi tutarl\u0131 m\u0131?<\/li>\n              <\/ul>\n              <div class=\"kk-mdr-auditor-intent\"><strong>Denet\u00e7inin amac\u0131:<\/strong> \u00dcr\u00fcn \u00fczerinde verilen bilgi, teknik dosyadaki g\u00fcvenlik ve performans kan\u0131tlar\u0131yla ayn\u0131 dili konu\u015fuyor mu?<\/div>\n            <\/article>\n\n            <article class=\"kk-mdr-question-card\">\n              <div class=\"kk-mdr-question-head\">\n                <span class=\"kk-mdr-number\">8<\/span>\n                <div>\n                  <h3>\u201cBu s\u00fcrecin sahibi kim ve kay\u0131tlar nas\u0131l y\u00f6netiliyor?\u201d<\/h3>\n                  <p>Denet\u00e7i sadece dok\u00fcman\u0131 de\u011fil, s\u00fcreci y\u00f6neten ki\u015fiyi, sorumlulu\u011fu, kay\u0131t disiplinini ve y\u00f6netim kontrol\u00fcn\u00fc g\u00f6rmek ister.<\/p>\n                <\/div>\n              <\/div>\n              <ul>\n                <li>Proses sahipleri ve vekaletleri tan\u0131ml\u0131 m\u0131?<\/li>\n                <li>Dok\u00fcman revizyonlar\u0131 ve onay kay\u0131tlar\u0131 izlenebilir mi?<\/li>\n                <li>\u0130\u00e7 denetim, CAPA ve y\u00f6netimin g\u00f6zden ge\u00e7irmesi MDR s\u00fcre\u00e7lerini kaps\u0131yor mu?<\/li>\n              <\/ul>\n              <div class=\"kk-mdr-auditor-intent\"><strong>Denet\u00e7inin amac\u0131:<\/strong> Sistem bir ki\u015finin haf\u0131zas\u0131na m\u0131 ba\u011fl\u0131, yoksa kurumsal ve s\u00fcrd\u00fcr\u00fclebilir \u015fekilde mi y\u00f6netiliyor?<\/div>\n            <\/article>\n          <\/div>\n        <\/section>\n\n        <section class=\"kk-mdr-section\" id=\"kk-mdr-kontrol-listesi\">\n          <h2>Denetim \u00f6ncesi pratik kontrol listesi<\/h2>\n          <p>\n            A\u015fa\u011f\u0131daki liste, MDR denetimi veya notified body submission \u00f6ncesi h\u0131zl\u0131 bir gap analizi yapmak i\u00e7in kullan\u0131labilir.\n          <\/p>\n\n          <ul class=\"kk-mdr-checklist\">\n            <li>\u00dcr\u00fcn tan\u0131m\u0131, kullan\u0131m amac\u0131, kullan\u0131c\u0131 profili ve kontraendikasyonlar t\u00fcm dok\u00fcmanlarda ayn\u0131 m\u0131?<\/li>\n            <li>S\u0131n\u0131fland\u0131rma gerek\u00e7esi MDR Ek VIII kural\u0131 ile a\u00e7\u0131k\u00e7a yaz\u0131lm\u0131\u015f m\u0131?<\/li>\n            <li>Uygunluk de\u011ferlendirme yolu cihaz s\u0131n\u0131f\u0131na g\u00f6re do\u011fru se\u00e7ilmi\u015f mi?<\/li>\n            <li>Teknik dosya MDR Ek II; PMS dok\u00fcmantasyonu Ek III mant\u0131\u011f\u0131na g\u00f6re indekslenmi\u015f mi?<\/li>\n            <li>GSPR tablosunda uygulanabilirlik karar\u0131, gerek\u00e7e ve kan\u0131t dok\u00fcman\u0131 birlikte verilmi\u015f mi?<\/li>\n            <li>Risk y\u00f6netimi ISO 14971 mant\u0131\u011f\u0131nda; tehlike, zarar, risk kontrol\u00fc ve art\u0131k risk izlenebilirli\u011fiyle haz\u0131rlanm\u0131\u015f m\u0131?<\/li>\n            <li>Klinik de\u011ferlendirme; literat\u00fcr, klinik veri, e\u015fde\u011ferlik ve PMCF karar\u0131yla desteklenmi\u015f mi?<\/li>\n            <li>Etiket ve IFU; risk kontrol \u00f6nlemleri, kullan\u0131m amac\u0131, semboller ve uyar\u0131larla uyumlu mu?<\/li>\n            <li>UDI-DI, Basic UDI-DI, model\/varyant, ambalaj seviyesi ve EUDAMED\/\u00dcTS verileri tutarl\u0131 m\u0131?<\/li>\n            <li>PMS plan\u0131, \u015fikayet y\u00f6netimi, trend analizi, CAPA ve risk dosyas\u0131 aras\u0131nda geri besleme kurulmu\u015f mu?<\/li>\n          <\/ul>\n\n          <div class=\"kk-mdr-warning\">\n            <strong>Sahada en s\u0131k g\u00f6r\u00fclen maj\u00f6r risk:<\/strong> Belgelerin tek tek var olmas\u0131 ama aralar\u0131nda ba\u011flant\u0131 olmamas\u0131. Denet\u00e7i genellikle bu kopuklu\u011fu; IFU iddias\u0131, risk kontrol\u00fc, klinik kan\u0131t, GSPR sat\u0131r\u0131 ve PMS \u00e7\u0131kt\u0131s\u0131 aras\u0131nda \u00e7apraz kontrol yaparak yakalar.\n          <\/div>\n        <\/section>\n\n        <section class=\"kk-mdr-section\">\n          <h2>Denetim sorusu hangi kan\u0131ta ba\u011flan\u0131r?<\/h2>\n          <p>\n            Denetim haz\u0131rl\u0131\u011f\u0131nda her soruya kar\u015f\u0131l\u0131k gelen kan\u0131t\u0131n \u00f6nceden belirlenmesi, g\u00f6r\u00fc\u015fme s\u0131ras\u0131nda g\u00fcvenli ve kurumsal bir cevap verilmesini sa\u011flar.\n          <\/p>\n\n          <div class=\"kk-mdr-table-wrap\">\n            <table class=\"kk-mdr-table\">\n              <thead>\n                <tr>\n                  <th>Denetim konusu<\/th>\n                  <th>Beklenen kan\u0131t<\/th>\n                  <th>S\u0131k hata<\/th>\n                  <th>\u0130yi uygulama<\/th>\n                <\/tr>\n              <\/thead>\n              <tbody>\n                <tr>\n                  <td>Rol ve sorumluluklar<\/td>\n                  <td>Organizasyon \u015femas\u0131, g\u00f6rev tan\u0131m\u0131, PRRC\/sorumlu ki\u015fi kay\u0131tlar\u0131<\/td>\n                  <td>Rol\u00fcn sadece prosed\u00fcrde yaz\u0131l\u0131 olmas\u0131<\/td>\n                  <td>S\u00fcre\u00e7 sahibi, vekil ve kay\u0131t ak\u0131\u015f\u0131n\u0131n g\u00f6sterilmesi<\/td>\n                <\/tr>\n                <tr>\n                  <td>Teknik dosya<\/td>\n                  <td>Ek II\/Ek III indeks yap\u0131s\u0131, teknik dosya kontrol listesi<\/td>\n                  <td>Belgelerin klas\u00f6rde da\u011f\u0131n\u0131k tutulmas\u0131<\/td>\n                  <td>Kan\u0131t dok\u00fcman kodu, revizyonu ve ba\u011flant\u0131 matrisi kullan\u0131lmas\u0131<\/td>\n                <\/tr>\n                <tr>\n                  <td>GSPR<\/td>\n                  <td>Uygulanabilirlik gerek\u00e7esi, kan\u0131t dok\u00fcman\u0131, risk\/klinik\/test ba\u011flant\u0131s\u0131<\/td>\n                  <td>Her sat\u0131ra \u201cuygundur\u201d yaz\u0131lmas\u0131<\/td>\n                  <td>Her gereklilik i\u00e7in izlenebilir kan\u0131t verilmesi<\/td>\n                <\/tr>\n                <tr>\n                  <td>Risk y\u00f6netimi<\/td>\n                  <td>Risk analiz dosyas\u0131, risk de\u011ferlendirme kriteri, art\u0131k risk karar\u0131<\/td>\n                  <td>PMS ve \u015fikayetlerin risk dosyas\u0131na yans\u0131mamas\u0131<\/td>\n                  <td>Risk dosyas\u0131n\u0131n CAPA, PMS, IFU ve klinik de\u011ferlendirmeyle ba\u011flant\u0131l\u0131 tutulmas\u0131<\/td>\n                <\/tr>\n                <tr>\n                  <td>Klinik de\u011ferlendirme<\/td>\n                  <td>CER, literat\u00fcr stratejisi, PMCF plan\u0131\/gerek\u00e7esi<\/td>\n                  <td>G\u00fcncel olmayan literat\u00fcr ve zay\u0131f e\u015fde\u011ferlik gerek\u00e7esi<\/td>\n                  <td>PMS verileriyle periyodik g\u00fcncelleme yap\u0131lmas\u0131<\/td>\n                <\/tr>\n                <tr>\n                  <td>Etiket \/ IFU \/ UDI<\/td>\n                  <td>Etiket taslaklar\u0131, IFU, sembol kontrol\u00fc, UDI kay\u0131tlar\u0131<\/td>\n                  <td>\u0130ddialar\u0131n teknik dosyadan farkl\u0131 olmas\u0131<\/td>\n                  <td>Risk kontrol \u00f6nlemleri ve \u00fcr\u00fcn varyantlar\u0131yla \u00e7apraz kontrol yap\u0131lmas\u0131<\/td>\n                <\/tr>\n              <\/tbody>\n            <\/table>\n          <\/div>\n        <\/section>\n\n        <section class=\"kk-mdr-section\">\n          <h2>Class I cihazlar i\u00e7in \u00f6zel not<\/h2>\n          <p>\n            Class I cihazlarda \u00fcretici kendi sorumlulu\u011fu alt\u0131nda uygunluk beyan\u0131 d\u00fczenleyebilir. Ancak bu, cihaz\u0131n \u201cbelgesiz\u201d piyasaya arz edilebilece\u011fi anlam\u0131na gelmez. Teknik dosya, risk y\u00f6netimi, klinik de\u011ferlendirme, etiket\/IFU, PMS ve uygunluk beyan\u0131 yine denetime haz\u0131r olmal\u0131d\u0131r.\n          <\/p>\n\n          <div class=\"kk-mdr-highlight\">\n            <strong>Notified body ne zaman devreye girer?<\/strong><br>\n            Standart Class I cihazlarda genellikle notified body gerekmez. Ancak cihaz steril ise <strong>Class Is<\/strong>, \u00f6l\u00e7\u00fcm fonksiyonu varsa <strong>Class Im<\/strong>, yeniden kullan\u0131labilir cerrahi alet ise <strong>Class Ir<\/strong> kapsam\u0131 de\u011ferlendirilmelidir.\n          <\/div>\n\n          <div class=\"kk-mdr-pill-row\">\n            <span class=\"kk-mdr-pill\">MDR Ek II<\/span>\n            <span class=\"kk-mdr-pill\">MDR Ek III<\/span>\n            <span class=\"kk-mdr-pill\">MDR Ek IV<\/span>\n            <span class=\"kk-mdr-pill\">MDR Ek VIII<\/span>\n            <span class=\"kk-mdr-pill\">ISO 14971<\/span>\n            <span class=\"kk-mdr-pill\">ISO 15223-1<\/span>\n            <span class=\"kk-mdr-pill\">ISO 20417<\/span>\n          <\/div>\n        <\/section>\n\n        <section class=\"kk-mdr-section\">\n          <h2>KaliteKit yakla\u015f\u0131m\u0131: denetime haz\u0131r teknik dosya mimarisi<\/h2>\n          <p>\n            KaliteKit\u2019te MDR denetim haz\u0131rl\u0131\u011f\u0131 yaln\u0131zca belge tamamlama olarak ele al\u0131nmaz. Ama\u00e7; \u00fcr\u00fcn ailesi, varyant, kullan\u0131m amac\u0131, risk s\u0131n\u0131f\u0131, teknik dosya, GSPR, klinik de\u011ferlendirme, PMS ve etiket\/IFU ba\u011flant\u0131lar\u0131n\u0131 tek sistemde izlenebilir hale getirmektir.\n          <\/p>\n\n          <div class=\"kk-mdr-service-grid\">\n            <div class=\"kk-mdr-service\">\n              <strong>MDR Teknik Dosya Gap Analizi<\/strong>\n              <span>Ek II\/Ek III yap\u0131s\u0131na g\u00f6re eksik, zay\u0131f ve tutars\u0131z alanlar\u0131n tespiti.<\/span>\n            <\/div>\n            <div class=\"kk-mdr-service\">\n              <strong>GSPR Kan\u0131t E\u015fle\u015ftirme<\/strong>\n              <span>Her GSPR maddesi i\u00e7in uygulanabilirlik, gerek\u00e7e ve kan\u0131t dok\u00fcman\u0131 ba\u011flant\u0131s\u0131.<\/span>\n            <\/div>\n            <div class=\"kk-mdr-service\">\n              <strong>Risk Y\u00f6netimi Revizyonu<\/strong>\n              <span>ISO 14971 mant\u0131\u011f\u0131nda tehlike, risk kontrol\u00fc, art\u0131k risk ve PMS ba\u011flant\u0131s\u0131.<\/span>\n            <\/div>\n            <div class=\"kk-mdr-service\">\n              <strong>Etiket \/ IFU \/ UDI Kontrol\u00fc<\/strong>\n              <span>\u00dcr\u00fcn iddialar\u0131, semboller, UDI-DI ve teknik dosya tutarl\u0131l\u0131\u011f\u0131n\u0131n kontrol\u00fc.<\/span>\n            <\/div>\n          <\/div>\n        <\/section>\n\n        <section class=\"kk-mdr-section kk-mdr-faq\">\n          <h2>S\u0131k sorulan k\u0131sa sorular<\/h2>\n\n          <details>\n            <summary>MDR denetiminde en \u00e7ok hangi konu sorun \u00e7\u0131kar\u0131r?<\/summary>\n            <div>\n              En s\u0131k sorun, dok\u00fcmanlar aras\u0131 tutars\u0131zl\u0131kt\u0131r. \u00d6rne\u011fin IFU\u2019da yer alan bir iddian\u0131n klinik de\u011ferlendirmede desteklenmemesi, risk kontrol \u00f6nleminin etikete yans\u0131mamas\u0131 veya PMS \u00e7\u0131kt\u0131s\u0131n\u0131n risk dosyas\u0131na geri d\u00f6nmemesi \u00f6nemli uygunsuzluklara yol a\u00e7abilir.\n            <\/div>\n          <\/details>\n\n          <details>\n            <summary>Class I cihazlarda klinik de\u011ferlendirme gerekir mi?<\/summary>\n            <div>\n              Evet. Class I cihazlarda da klinik de\u011ferlendirme mant\u0131\u011f\u0131 gerekir. Kapsam ve derinlik cihaz\u0131n risk profiline g\u00f6re de\u011fi\u015febilir; ancak \u201cy\u0131llard\u0131r kullan\u0131l\u0131yor\u201d ifadesi tek ba\u015f\u0131na klinik kan\u0131t olarak yeterli g\u00f6r\u00fclmez.\n            <\/div>\n          <\/details>\n\n          <details>\n            <summary>PMS plan\u0131 varsa ayr\u0131ca PMS raporu gerekir mi?<\/summary>\n            <div>\n              Plan, ne yap\u0131laca\u011f\u0131n\u0131 tan\u0131mlar; rapor ise sahadan gelen verinin nas\u0131l de\u011ferlendirildi\u011fini g\u00f6sterir. Denet\u00e7i genellikle PMS plan\u0131 ile PMS \u00e7\u0131kt\u0131lar\u0131n\u0131n risk y\u00f6netimi, klinik de\u011ferlendirme ve CAPA s\u00fcre\u00e7lerine geri beslenip beslenmedi\u011fini g\u00f6rmek ister.\n            <\/div>\n          <\/details>\n\n          <details>\n            <summary>GSPR tablosunda \u201cuygundur\u201d yazmak yeterli mi?<\/summary>\n            <div>\n              Hay\u0131r. Her uygulanabilir gereklilik i\u00e7in kan\u0131t dok\u00fcman\u0131, gerek\u00e7e, risk ba\u011flant\u0131s\u0131 ve gerekiyorsa test\/klinik\/etiket\/IFU referans\u0131 verilmelidir. Uygulanamaz denilen maddelerde de neden uygulanamaz oldu\u011fu a\u00e7\u0131k\u00e7a yaz\u0131lmal\u0131d\u0131r.\n            <\/div>\n          <\/details>\n        <\/section>\n      <\/main>\n\n      <aside class=\"kk-mdr-sidebar\" aria-label=\"MDR denetim haz\u0131rl\u0131\u011f\u0131 yan paneli\">\n        <div class=\"kk-mdr-sidebar-box\">\n          <h3>H\u0131zl\u0131 denetim \u00f6zeti<\/h3>\n          <p>Denet\u00e7i \u00e7o\u011fu zaman tek belgeye de\u011fil, belgeler aras\u0131ndaki ba\u011flant\u0131ya bakar.<\/p>\n          <ul class=\"kk-mdr-mini-list\">\n            <li>Teknik dosya g\u00fcncel mi?<\/li>\n            <li>GSPR kan\u0131tlar\u0131 izlenebilir mi?<\/li>\n            <li>Risk dosyas\u0131 PMS ile besleniyor mu?<\/li>\n            <li>Klinik de\u011ferlendirme g\u00fcncel mi?<\/li>\n            <li>Etiket\/IFU iddialar\u0131 kan\u0131tl\u0131 m\u0131?<\/li>\n          <\/ul>\n        <\/div>\n\n        <div class=\"kk-mdr-sidebar-box\">\n          <h3>Kendi haz\u0131rl\u0131\u011f\u0131n\u0131z\u0131 puanlay\u0131n<\/h3>\n          <p>A\u015fa\u011f\u0131daki maddeleri i\u015faretleyerek h\u0131zl\u0131 \u00f6n risk seviyenizi g\u00f6r\u00fcn.<\/p>\n          <div class=\"kk-mdr-score\" id=\"kkMdrScoreBox\">\n            <label><input type=\"checkbox\" data-kk-score> Teknik dosya indeksim Ek II\/Ek III mant\u0131\u011f\u0131nda haz\u0131r.<\/label>\n            <label><input type=\"checkbox\" data-kk-score> GSPR tablomda kan\u0131t dok\u00fcman kodlar\u0131 var.<\/label>\n            <label><input type=\"checkbox\" data-kk-score> Risk dosyam PMS ve \u015fikayetlerle g\u00fcncelleniyor.<\/label>\n            <label><input type=\"checkbox\" data-kk-score> CER ve PMCF gerek\u00e7em g\u00fcncel.<\/label>\n            <label><input type=\"checkbox\" data-kk-score> Etiket, IFU ve UDI kay\u0131tlar\u0131m tutarl\u0131.<\/label>\n            <div class=\"kk-mdr-score-result\" id=\"kkMdrScoreResult\">Haz\u0131rl\u0131k seviyesi: 0\/5<\/div>\n          <\/div>\n        <\/div>\n\n        <div class=\"kk-mdr-sidebar-box\">\n          <h3>\u0130lgili KaliteKit ara\u00e7lar\u0131<\/h3>\n          <ul class=\"kk-mdr-mini-list\">\n            <li><a class=\"kk-mdr-link\" href=\"https:\/\/www.kalitekit.com.tr\/mdr-teknik-dosya-kontrol-kit\/\">MDR Teknik Dosya Kontrol Kiti<\/a><\/li>\n            <li><a class=\"kk-mdr-link\" href=\"https:\/\/www.kalitekit.com.tr\/iso-14971-risk-analiz-kiti\/\">ISO 14971 Risk Analiz Kiti<\/a><\/li>\n            <li><a class=\"kk-mdr-link\" href=\"https:\/\/www.kalitekit.com.tr\/uygunluk-beyani-olusturucu\/\">Uygunluk Beyan\u0131 Olu\u015fturucu<\/a><\/li>\n            <li><a class=\"kk-mdr-link\" href=\"https:\/\/www.kalitekit.com.tr\/tibbi-cihaz-etiket-olusturma-iso-15223\/\">T\u0131bbi Cihaz Etiket Olu\u015fturma<\/a><\/li>\n          <\/ul>\n        <\/div>\n      <\/aside>\n    <\/div>\n\n    <section class=\"kk-mdr-cta\">\n      <h2>MDR denetimine dosya de\u011fil, sistem haz\u0131rlay\u0131n.<\/h2>\n      <p>\n        Teknik dosyan\u0131z\u0131n denetimde nas\u0131l g\u00f6r\u00fcnece\u011fini, GSPR-risk-klinik-PMS ba\u011flant\u0131lar\u0131n\u0131z\u0131n yeterli olup olmad\u0131\u011f\u0131n\u0131 ve etiket\/IFU\/UDI tutarl\u0131l\u0131\u011f\u0131n\u0131z\u0131 \u00f6nceden g\u00f6rmek i\u00e7in KaliteKit ile \u00f6n de\u011ferlendirme yapabilirsiniz.\n      <\/p>\n      <div class=\"kk-mdr-hero-actions\">\n        <a class=\"kk-mdr-btn kk-mdr-btn-primary\" href=\"https:\/\/www.kalitekit.com.tr\/iletisim\/\">KaliteKit ile ileti\u015fime ge\u00e7<\/a>\n        <a class=\"kk-mdr-btn kk-mdr-btn-secondary\" href=\"https:\/\/www.kalitekit.com.tr\/hizmetler\/\">Hizmetleri incele<\/a>\n      <\/div>\n    <\/section>\n  <\/div>\n\n  <script>\n    (function () {\n      var root = document.querySelector('.kk-mdr-audit-page');\n      if (!root) return;\n\n      var checks = root.querySelectorAll('[data-kk-score]');\n      var result = root.querySelector('#kkMdrScoreResult');\n\n      function updateScore() {\n        var total = checks.length;\n        var checked = 0;\n\n        checks.forEach(function (item) {\n          if (item.checked) checked++;\n        });\n\n        var message = 'Haz\u0131rl\u0131k seviyesi: ' + checked + '\/' + total;\n\n        if (checked <= 1) {\n          message += ' \u2014 \u00d6ncelik: gap analizi yap\u0131lmal\u0131';\n        } else if (checked <= 3) {\n          message += ' \u2014 Orta seviye: ba\u011flant\u0131lar g\u00fc\u00e7lendirilmeli';\n        } else if (checked === 4) {\n          message += ' \u2014 \u0130yi seviye: final tutarl\u0131l\u0131k kontrol\u00fc \u00f6nerilir';\n        } else {\n          message += ' \u2014 G\u00fc\u00e7l\u00fc seviye: denetim provas\u0131 yap\u0131labilir';\n        }\n\n        result.textContent = message;\n      }\n\n      checks.forEach(function (item) {\n        item.addEventListener('change', updateScore);\n      });\n\n      updateScore();\n    })();\n  <\/script>\n<\/section>\n<!-- KaliteKit | MDR Denetim Sorular\u0131 Kurumsal Mobil Uyumlu \u0130\u00e7erik Biti\u015f -->\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>MDR denetimlerine giren firmalarla \u00e7al\u0131\u015f\u0131rken hep ayn\u0131 c\u00fcmleyle kar\u015f\u0131la\u015f\u0131yorum:<\/p>\n<p>\u201cDenetimde ne soracaklar?\u201d<\/p>\n<p>Asl\u0131nda do\u011fru soru biraz daha farkl\u0131 olmal\u0131:<\/p>\n<p>\u201cDenet\u00e7i bu soruyla neyi anlamaya \u00e7al\u0131\u015f\u0131yor?\u201d<\/p>\n<p>\u00c7\u00fcnk\u00fc MDR denetimleri ezber cevaplardan \u00e7ok, sistemin ger\u00e7ekten i\u015fleyip i\u015flemedi\u011fini test eder. Sahada en s\u0131k kar\u015f\u0131la\u015ft\u0131\u011f\u0131m sorular\u0131 ve bu sorular\u0131n arkas\u0131ndaki beklentiyi payla\u015fmak istiyorum.<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","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":"","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":""},"categories":[122],"tags":[],"class_list":["post-10277","post","type-post","status-publish","format-standard","hentry","category-blog"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/10277","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/post"}],"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=10277"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/10277\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=10277"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/categories?post=10277"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/tags?post=10277"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}