{"id":13874,"date":"2026-05-19T13:26:37","date_gmt":"2026-05-19T13:26:37","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=13874"},"modified":"2026-06-03T08:34:24","modified_gmt":"2026-06-03T08:34:24","slug":"saglik-raporlari-yonetmeligi-tibbi-cihaz-firmalarini-nasil-etkiler","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/saglik-raporlari-yonetmeligi-tibbi-cihaz-firmalarini-nasil-etkiler\/","title":{"rendered":"Sa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi T\u0131bbi Cihaz Firmalar\u0131n\u0131 Nas\u0131l Etkiler?"},"content":{"rendered":"\n<!--\nSEO Title:\nSa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi T\u0131bbi Cihaz Firmalar\u0131n\u0131 Nas\u0131l Etkiler? \u00dcTS, Teknik Dosya ve Belgelendirme Rehberi\n\nMeta Description:\nSa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi t\u0131bbi cihaz firmalar\u0131 i\u00e7in ne anlama geliyor? e-Nab\u0131z, e-Rapor, sa\u011fl\u0131k durum belgesi, \u00dcTS kayd\u0131, teknik dosya, etiket, IFU ve belgelendirme a\u00e7\u0131s\u0131ndan kapsaml\u0131 rehber.\n\nSuggested URL Slug:\nsaglik-raporlari-yonetmeligi-tibbi-cihaz-firmalarini-nasil-etkiler\n\nFocus Keyword:\nSa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi t\u0131bbi cihaz firmalar\u0131\n-->\n\n<style>\n  .kk-health-wrap,\n  .kk-health-wrap *,\n  .kk-health-wrap *::before,\n  .kk-health-wrap *::after {\n    box-sizing: border-box;\n  }\n\n  .kk-health-wrap {\n    width: 100%;\n    max-width: 1180px;\n    margin: 0 auto;\n    padding: 24px 14px;\n    font-family: Arial, Helvetica, sans-serif;\n    color: #1f2937;\n    line-height: 1.75;\n    background: #ffffff;\n    overflow-x: hidden;\n  }\n\n  .kk-health-hero {\n    width: 100%;\n    background: linear-gradient(135deg, #0f3f68 0%, #0f6ea8 48%, #22a6b3 100%);\n    color: #ffffff;\n    border-radius: 26px;\n    padding: 46px 34px;\n    margin-bottom: 30px;\n    box-shadow: 0 18px 45px rgba(15, 63, 104, 0.22);\n    position: relative;\n    overflow: 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class=\"kk-health-hero\">\n    <span class=\"kk-health-badge\">Sa\u011fl\u0131k Raporlar\u0131 \u2022 e-Nab\u0131z \u2022 \u00dcTS \u2022 Teknik Dosya<\/span>\n\n    <h2 itemprop=\"headline\">\n      Sa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi T\u0131bbi Cihaz Firmalar\u0131n\u0131 Nas\u0131l Etkiler?\n    <\/h2>\n\n    <p itemprop=\"description\">\n      Sa\u011fl\u0131k raporlar\u0131nda dijital ba\u015fvuru, e-Rapor, sa\u011fl\u0131k durum belgesi ve sa\u011fl\u0131k kurulu s\u00fcre\u00e7lerinde yeni d\u00f6nem ba\u015flad\u0131. Bu de\u011fi\u015fiklikler, \u00f6zellikle sa\u011fl\u0131k raporuna ba\u011fl\u0131 temin edilen t\u0131bbi cihazlarda \u00dcTS kayd\u0131, teknik dosya, etiket, IFU ve belgelendirme uyumunu daha \u00f6nemli hale getiriyor.\n    <\/p>\n\n    <div class=\"kk-health-meta\">\n      <span>G\u00fcncel Mevzuat Rehberi<\/span>\n      <span>Okuma S\u00fcresi: 10-13 dk<\/span>\n      <span>KaliteKit Bilgilendirme Yaz\u0131s\u0131<\/span>\n    <\/div>\n  <\/header>\n\n  <div class=\"kk-health-layout\">\n\n    <aside class=\"kk-health-toc\">\n      <strong>\u0130\u00e7indekiler<\/strong>\n      <a href=\"#giris\">Giri\u015f<\/a>\n      <a href=\"#one-cikanlar\">Yeni Y\u00f6netmelikte \u00d6ne \u00c7\u0131kanlar<\/a>\n      <a href=\"#tibbi-cihaz-firmalari\">T\u0131bbi Cihaz Firmalar\u0131 A\u00e7\u0131s\u0131ndan \u00d6nemi<\/a>\n      <a href=\"#uts\">\u00dcTS A\u00e7\u0131s\u0131ndan Etkileri<\/a>\n      <a href=\"#teknik-dosya\">Teknik Dosya A\u00e7\u0131s\u0131ndan Etkileri<\/a>\n      <a href=\"#etiket-ifu\">Etiket ve IFU A\u00e7\u0131s\u0131ndan Etkileri<\/a>\n      <a href=\"#belgelendirme\">Belgelendirme A\u00e7\u0131s\u0131ndan Etkileri<\/a>\n      <a href=\"#sgk\">SGK ve Raporlu \u00dcr\u00fcn S\u00fcre\u00e7leri<\/a>\n      <a href=\"#kontrol-listesi\">Firma Kontrol Listesi<\/a>\n      <a href=\"#sss\">S\u0131k Sorulan Sorular<\/a>\n    <\/aside>\n\n    <main class=\"kk-health-content\">\n\n      <section id=\"giris\">\n        <h2>Giri\u015f: Sa\u011fl\u0131k Raporlar\u0131nda Dijital ve Standart D\u00f6nem<\/h2>\n\n        <p>\n          Sa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi, sa\u011fl\u0131k raporlar\u0131n\u0131n d\u00fczenlenmesi, ba\u015fvurusu, de\u011ferlendirilmesi, kurul s\u00fcre\u00e7leri, itiraz mekanizmalar\u0131 ve elektronik sistemler \u00fczerinden y\u00fcr\u00fct\u00fclmesi a\u00e7\u0131s\u0131ndan \u00f6nemli bir d\u00fczenleme getirmektedir.\n        <\/p>\n\n        <p>\n          Bu y\u00f6netmelik do\u011frudan t\u0131bbi cihaz firmalar\u0131na yeni bir CE belgesi veya teknik dosya zorunlulu\u011fu getirmez. Ancak sa\u011fl\u0131k raporlar\u0131n\u0131n daha dijital, daha izlenebilir ve daha standart hale gelmesi; \u00f6zellikle rapora ba\u011fl\u0131 temin edilen medikal \u00fcr\u00fcnlerde firma, \u00fcr\u00fcn, barkod, \u00dcTS kayd\u0131 ve teknik dok\u00fcmantasyon uyumunu daha \u00f6nemli hale getirir.\n        <\/p>\n\n        <div class=\"kk-health-highlight\">\n          <strong>\u00d6zet:<\/strong> Sa\u011fl\u0131k raporlar\u0131n\u0131n dijitalle\u015fmesi yaln\u0131zca hastaneleri ilgilendirmez. Raporla temin edilen t\u0131bbi cihazlarda \u00fcr\u00fcn bilgisi, \u00dcTS kayd\u0131, teknik dosya, etiket ve kullan\u0131m talimat\u0131 art\u0131k daha dikkatli y\u00f6netilmelidir.\n        <\/div>\n      <\/section>\n\n      <section id=\"one-cikanlar\">\n        <h2>Sa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi\u2019nde \u00d6ne \u00c7\u0131kan Yeni Ba\u015fl\u0131klar<\/h2>\n\n        <p>\n          Yeni d\u00fczenleme ile sa\u011fl\u0131k raporlar\u0131nda dijital ba\u015fvuru, standart format, sa\u011fl\u0131k durum belgesi, e-Rapor sistemi, sa\u011fl\u0131k kurulu s\u00fcre\u00e7lerinde kolayla\u015ft\u0131rma ve rapor ba\u015fvuru merkezi gibi konular \u00f6ne \u00e7\u0131kmaktad\u0131r.\n        <\/p>\n\n        <div class=\"kk-health-card-grid\">\n          <div class=\"kk-health-card\">\n            <h3>1. e-Nab\u0131z \u00dczerinden Dijital Ba\u015fvuru<\/h3>\n            <p>\n              Sa\u011fl\u0131k raporlar\u0131nda ba\u015fvurular\u0131n dijital kanallar \u00fczerinden yap\u0131lmas\u0131, yaz\u0131l\u0131 dilek\u00e7e ve fiziksel evrak s\u00fcre\u00e7lerinin azalt\u0131lmas\u0131 hedeflenmektedir.\n            <\/p>\n          <\/div>\n\n          <div class=\"kk-health-card\">\n            <h3>2. Sa\u011fl\u0131k Durum Belgesi<\/h3>\n            <p>\n              Baz\u0131 sosyal ve sportif faaliyetler i\u00e7in hekime gitmeden e-Nab\u0131z \u00fczerinden sa\u011fl\u0131k durum belgesi al\u0131nabilmesi yeni d\u00f6nemin dikkat \u00e7eken ba\u015fl\u0131klar\u0131ndan biridir.\n            <\/p>\n          <\/div>\n\n          <div class=\"kk-health-card\">\n            <h3>3. Karar Destek Sistemi<\/h3>\n            <p>\n              Tek hekim raporu ba\u015fvurular\u0131nda ki\u015finin engel, tan\u0131, ila\u00e7 kullan\u0131m\u0131 veya sa\u011fl\u0131k sorunu beyan\u0131 yoksa sa\u011fl\u0131k durum belgesi d\u00fczenlenmesi hedeflenmektedir.\n            <\/p>\n          <\/div>\n\n          <div class=\"kk-health-card\">\n            <h3>4. e-Rapor Ar\u015fivleme Kolayl\u0131\u011f\u0131<\/h3>\n            <p>\n              e-Rapor sistemi \u00fczerinden d\u00fczenlenen raporlar\u0131n ayr\u0131ca fiziki olarak ar\u015fivlenmesine gerek kalmamas\u0131, sa\u011fl\u0131k kurulu\u015flar\u0131 i\u00e7in operasyonel kolayl\u0131k sa\u011flayabilir.\n            <\/p>\n          <\/div>\n\n          <div class=\"kk-health-card\">\n            <h3>5. Sa\u011fl\u0131k Kurulu Yap\u0131s\u0131<\/h3>\n            <p>\n              Tam te\u015fekk\u00fcll\u00fc ve \u00fc\u00e7 hekimli olmak \u00fczere iki temel sa\u011fl\u0131k kurulu yap\u0131s\u0131n\u0131n d\u00fczenlenmesi, rapor s\u00fcre\u00e7lerinin daha sistematik y\u00fcr\u00fct\u00fclmesini sa\u011flayabilir.\n            <\/p>\n          <\/div>\n\n          <div class=\"kk-health-card\">\n            <h3>6. Rapor Ba\u015fvuru Merkezi<\/h3>\n            <p>\n              \u0130kinci ve \u00fc\u00e7\u00fcnc\u00fc basamak sa\u011fl\u0131k hizmet sunucular\u0131nda rapor i\u015flemlerinin tek noktadan ba\u015flat\u0131lmas\u0131, takip edilmesi ve sonu\u00e7land\u0131r\u0131lmas\u0131 hedeflenmektedir.\n            <\/p>\n          <\/div>\n        <\/div>\n\n        <div class=\"kk-health-update\">\n          <strong>T\u0131bbi cihaz firmalar\u0131 a\u00e7\u0131s\u0131ndan kritik nokta:<\/strong>\n          <p>\n            Sa\u011fl\u0131k raporu s\u00fcre\u00e7leri dijitalle\u015ftik\u00e7e, rapora ba\u011fl\u0131 verilen medikal \u00fcr\u00fcnlerde \u201crapor \u2192 \u00fcr\u00fcn \u2192 barkod \u2192 \u00dcTS kayd\u0131 \u2192 teknik dosya \u2192 etiket\/IFU\u201d zinciri daha fazla \u00f6nem kazan\u0131r.\n          <\/p>\n        <\/div>\n\n        <div class=\"kk-health-flow\">\n          <div>Sa\u011fl\u0131k Raporu<\/div>\n          <div>\u00dcr\u00fcn Temini<\/div>\n          <div>Barkod \/ UDI<\/div>\n          <div>\u00dcTS Kayd\u0131<\/div>\n          <div>Teknik Dosya<\/div>\n        <\/div>\n      <\/section>\n\n      <section id=\"tibbi-cihaz-firmalari\">\n        <h2>T\u0131bbi Cihaz Firmalar\u0131 A\u00e7\u0131s\u0131ndan Neden \u00d6nemli?<\/h2>\n\n        <p>\n          T\u0131bbi cihaz sekt\u00f6r\u00fc yaln\u0131zca \u00fcretim, ithalat veya sat\u0131\u015ftan ibaret de\u011fildir. Bir\u00e7ok t\u0131bbi cihaz ve medikal \u00fcr\u00fcn; hekim raporu, sa\u011fl\u0131k kurulu raporu, re\u00e7ete, SGK geri \u00f6deme s\u00fcreci, hasta kullan\u0131m ihtiyac\u0131 ve \u00dcTS kayd\u0131 ile do\u011frudan ili\u015fkilidir.\n        <\/p>\n\n        <p>\n          Bu nedenle sa\u011fl\u0131k raporlar\u0131n\u0131n daha dijital ve kontrol edilebilir hale gelmesi, firmalar\u0131n \u00fcr\u00fcn bilgilerini daha disiplinli y\u00f6netmesini gerektirir.\n        <\/p>\n\n        <h3>\u00d6zellikle Etkilenebilecek \u00dcr\u00fcn Gruplar\u0131<\/h3>\n\n        <ul>\n          <li>Ortez, protez ve destek \u00fcr\u00fcnleri<\/li>\n          <li>\u0130\u015fitme cihazlar\u0131<\/li>\n          <li>G\u00f6rme destek \u00fcr\u00fcnleri ve optik \u00fcr\u00fcnler<\/li>\n          <li>Solunum cihazlar\u0131<\/li>\n          <li>Hasta bak\u0131m \u00fcr\u00fcnleri<\/li>\n          <li>Evde kullan\u0131lan t\u0131bbi cihazlar<\/li>\n          <li>Rehabilitasyon \u00fcr\u00fcnleri<\/li>\n          <li>Engelli sa\u011fl\u0131k raporu ile temin edilen \u00fcr\u00fcnler<\/li>\n          <li>T\u0131bbi malzeme kullan\u0131m raporuna konu olabilecek \u00fcr\u00fcnler<\/li>\n          <li>SGK geri \u00f6deme s\u00fcrecine dahil medikal \u00fcr\u00fcnler<\/li>\n        <\/ul>\n\n        <div class=\"kk-health-warning\">\n          <strong>Dikkat:<\/strong> Sa\u011fl\u0131k raporu ile temin edilen bir \u00fcr\u00fcn\u00fcn \u00dcTS kayd\u0131, etiketi, barkodu, teknik dosyas\u0131 ve kullan\u0131m amac\u0131 aras\u0131nda uyumsuzluk varsa; sat\u0131\u015f, geri \u00f6deme, denetim veya hasta g\u00fcvenli\u011fi a\u00e7\u0131s\u0131ndan sorun ya\u015fanabilir.\n        <\/div>\n      <\/section>\n\n      <section id=\"uts\">\n        <h2>\u00dcTS A\u00e7\u0131s\u0131ndan Ne Anlama Geliyor?<\/h2>\n\n        <p>\n          \u00dcTS, T\u00fcrkiye\u2019de t\u0131bbi cihazlar\u0131n firma, belge ve \u00fcr\u00fcn kay\u0131tlar\u0131n\u0131n y\u00f6netildi\u011fi temel sistemdir. Sa\u011fl\u0131k raporlar\u0131n\u0131n dijitalle\u015fmesi, \u00dcTS kay\u0131tlar\u0131n\u0131n do\u011fru ve g\u00fcncel tutulmas\u0131n\u0131 daha \u00f6nemli hale getirir.\n        <\/p>\n\n        <h3>1. \u00dcr\u00fcn Bilgileri Do\u011fru Olmal\u0131<\/h3>\n        <p>\n          Sa\u011fl\u0131k raporunda, re\u00e7etede veya \u00fcr\u00fcn temin s\u00fcrecinde kullan\u0131lan \u00fcr\u00fcn ile \u00dcTS\u2019de kay\u0131tl\u0131 \u00fcr\u00fcn bilgileri uyumlu olmal\u0131d\u0131r. \u00dcr\u00fcn ad\u0131, marka, model, barkod, beden, \u00f6l\u00e7\u00fc, kullan\u0131m amac\u0131 ve \u00fcr\u00fcn tipi bilgilerinin do\u011fru girilmesi gerekir.\n        <\/p>\n\n        <h3>2. Barkod ve UDI Bilgileri Tutarl\u0131 Olmal\u0131<\/h3>\n        <p>\n          Farkl\u0131 beden, model, \u00f6l\u00e7\u00fc veya varyantlara sahip \u00fcr\u00fcnlerde tek barkodla t\u00fcm \u00fcr\u00fcnleri y\u00f6netmeye \u00e7al\u0131\u015fmak izlenebilirlik a\u00e7\u0131s\u0131ndan risk olu\u015fturabilir. Her \u00fcr\u00fcn varyant\u0131 i\u00e7in barkod, GTIN, UDI-DI ve Basic UDI-DI mant\u0131\u011f\u0131 do\u011fru kurulmal\u0131d\u0131r.\n        <\/p>\n\n        <h3>3. \u00dcr\u00fcn-Hasta-Rapor Ba\u011flant\u0131s\u0131 G\u00fc\u00e7lenir<\/h3>\n        <p>\n          \u00dcTS \u00fcr\u00fcn\u00fcn piyasadaki hareketini izlerken, sa\u011fl\u0131k raporu hastan\u0131n t\u0131bbi ihtiyac\u0131n\u0131 belgeleyebilir. Bu iki yap\u0131 birlikte d\u00fc\u015f\u00fcn\u00fcld\u00fc\u011f\u00fcnde, gelecekte \u00fcr\u00fcn-hasta-rapor ba\u011flant\u0131s\u0131n\u0131n daha fazla sorgulanmas\u0131 beklenebilir.\n        <\/p>\n\n        <div class=\"kk-health-success\">\n          <strong>Pratik kontrol:<\/strong> \u00dcTS\u2019de kay\u0131tl\u0131 \u00fcr\u00fcn ad\u0131, etikette yazan \u00fcr\u00fcn ad\u0131, teknik dosyadaki \u00fcr\u00fcn tan\u0131m\u0131 ve uygunluk beyan\u0131ndaki \u00fcr\u00fcn kapsam\u0131 ayn\u0131 m\u0131?\n        <\/div>\n      <\/section>\n\n      <section id=\"teknik-dosya\">\n        <h2>Teknik Dosya A\u00e7\u0131s\u0131ndan Ne Anlama Geliyor?<\/h2>\n\n        <p>\n          Sa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi teknik dosyaya do\u011frudan yeni bir belge eklememektedir. Ancak t\u0131bbi cihaz teknik dosyas\u0131; \u00fcr\u00fcn\u00fcn kullan\u0131m amac\u0131, hedef hasta grubu, endikasyonlar\u0131, kontrendikasyonlar\u0131, riskleri, etiket bilgileri ve kullan\u0131m talimat\u0131 ile bir b\u00fct\u00fcn olarak de\u011ferlendirilmelidir.\n        <\/p>\n\n        <h3>Kullan\u0131m Amac\u0131 Net Olmal\u0131<\/h3>\n        <p>\n          Sa\u011fl\u0131k raporu ile temin edilen \u00fcr\u00fcnlerde kullan\u0131m amac\u0131 belirsiz olmamal\u0131d\u0131r. \u00dcr\u00fcn hangi hasta grubunda, hangi t\u0131bbi ihtiya\u00e7 i\u00e7in ve hangi kullan\u0131m s\u0131n\u0131rlar\u0131 i\u00e7inde kullan\u0131lacaksa teknik dosyada a\u00e7\u0131k\u00e7a tan\u0131mlanmal\u0131d\u0131r.\n        <\/p>\n\n        <div class=\"kk-health-highlight\">\n          <strong>Zay\u0131f ifade:<\/strong> Bel a\u011fr\u0131s\u0131 i\u00e7in kullan\u0131l\u0131r.<br>\n          <strong>Daha do\u011fru ifade:<\/strong> Bel b\u00f6lgesine harici destek sa\u011flamak, post\u00fcr kontrol\u00fcne yard\u0131mc\u0131 olmak ve hekimin uygun g\u00f6rd\u00fc\u011f\u00fc durumlarda konservatif tedavi s\u00fcrecini desteklemek amac\u0131yla kullan\u0131lan non-invaziv ortopedik destek \u00fcr\u00fcn\u00fcd\u00fcr.\n        <\/div>\n\n        <h3>Endikasyon ve Kontrendikasyonlar Belirtilmeli<\/h3>\n        <p>\n          Sa\u011fl\u0131k raporu ile \u00fcr\u00fcn temin edilen durumlarda, \u00fcr\u00fcn\u00fcn hangi hasta grubunda kullan\u0131labilece\u011fi ve hangi durumlarda kullan\u0131lmamas\u0131 gerekti\u011fi teknik dosyada, etikette ve kullan\u0131m talimat\u0131nda uyumlu \u015fekilde belirtilmelidir.\n        <\/p>\n\n        <h3>Risk Analizi G\u00fcncellenmeli<\/h3>\n        <p>\n          Risk analizinde yaln\u0131zca \u00fcretim hatalar\u0131 de\u011fil, hasta kullan\u0131m senaryolar\u0131 da de\u011ferlendirilmelidir. Yanl\u0131\u015f \u00fcr\u00fcn verilmesi, yanl\u0131\u015f beden se\u00e7imi, uzun s\u00fcreli kullan\u0131m, cilt tahri\u015fi, alerjik reaksiyon, yanl\u0131\u015f temizlik ve kullan\u0131m talimat\u0131n\u0131n anla\u015f\u0131lmamas\u0131 gibi riskler ele al\u0131nmal\u0131d\u0131r.\n        <\/p>\n      <\/section>\n\n      <section id=\"etiket-ifu\">\n        <h2>Etiket ve Kullan\u0131m Talimat\u0131 A\u00e7\u0131s\u0131ndan Etkileri<\/h2>\n\n        <p>\n          Sa\u011fl\u0131k raporu ile temin edilen \u00fcr\u00fcnlerde kullan\u0131c\u0131 genellikle hasta, hasta yak\u0131n\u0131 veya sa\u011fl\u0131k personelidir. Bu nedenle etiket ve kullan\u0131m talimat\u0131 sade, anla\u015f\u0131l\u0131r ve teknik dosya ile uyumlu olmal\u0131d\u0131r.\n        <\/p>\n\n        <h3>Etiket ve IFU\u2019da Bulunmas\u0131 Gereken Temel Bilgiler<\/h3>\n\n        <ul>\n          <li>\u00dcr\u00fcn ad\u0131<\/li>\n          <li>Model, beden veya \u00f6l\u00e7\u00fc bilgisi<\/li>\n          <li>\u00dcretici ve varsa ithalat\u00e7\u0131 bilgisi<\/li>\n          <li>Barkod, UDI-DI veya ilgili tan\u0131mlay\u0131c\u0131 bilgiler<\/li>\n          <li>Lot veya seri numaras\u0131<\/li>\n          <li>Kullan\u0131m amac\u0131<\/li>\n          <li>Endikasyon ve kontrendikasyonlar<\/li>\n          <li>Uyar\u0131lar ve \u00f6nlemler<\/li>\n          <li>Saklama ko\u015fullar\u0131<\/li>\n          <li>Temizlik ve bak\u0131m bilgisi<\/li>\n          <li>Kullan\u0131m \u00f6mr\u00fc veya raf \u00f6mr\u00fc<\/li>\n          <li>CE i\u015fareti ve ilgili semboller<\/li>\n        <\/ul>\n\n        <div class=\"kk-health-warning\">\n          <strong>S\u0131k hata:<\/strong> \u00dcr\u00fcn kataloglar\u0131nda veya web sitesinde yazan kullan\u0131m iddialar\u0131, teknik dosya ve IFU\u2019da kar\u015f\u0131l\u0131\u011f\u0131 olmadan kullan\u0131lmamal\u0131d\u0131r. Bu durum denetimlerde uygunsuzluk riski olu\u015fturabilir.\n        <\/div>\n      <\/section>\n\n      <section id=\"belgelendirme\">\n        <h2>Belgelendirme A\u00e7\u0131s\u0131ndan Ne Anlama Geliyor?<\/h2>\n\n        <p>\n          Yeni sa\u011fl\u0131k raporu d\u00fczenlemesi t\u0131bbi cihaz firmalar\u0131na do\u011frudan yeni bir CE veya ISO 13485 belgesi alma zorunlulu\u011fu getirmez. Ancak belge y\u00f6netimi, kay\u0131t tutarl\u0131l\u0131\u011f\u0131 ve teknik dosya disiplini a\u00e7\u0131s\u0131ndan firmalar\u0131n daha dikkatli olmas\u0131 gerekir.\n        <\/p>\n\n        <div class=\"kk-health-card-grid\">\n          <div class=\"kk-health-card\">\n            <h3>CE Uygunlu\u011fu<\/h3>\n            <p>\n              \u00dcr\u00fcn piyasaya arz ediliyorsa, ilgili t\u0131bbi cihaz mevzuat\u0131na uygun \u015fekilde CE i\u015faretlemesi yap\u0131lmal\u0131 ve uygunluk de\u011ferlendirmesi tamamlanmal\u0131d\u0131r.\n            <\/p>\n          <\/div>\n\n          <div class=\"kk-health-card\">\n            <h3>ISO 13485<\/h3>\n            <p>\n              Kalite y\u00f6netim sistemi; izlenebilirlik, kay\u0131t kontrol\u00fc, \u015fikayet y\u00f6netimi, d\u00fczeltici faaliyet ve tedarik\u00e7i y\u00f6netimi a\u00e7\u0131s\u0131ndan g\u00fc\u00e7l\u00fc bir altyap\u0131 sa\u011flar.\n            <\/p>\n          <\/div>\n\n          <div class=\"kk-health-card\">\n            <h3>Uygunluk Beyan\u0131<\/h3>\n            <p>\n              \u00dcr\u00fcn ad\u0131, model, risk s\u0131n\u0131f\u0131, mevzuat referans\u0131, standartlar, \u00fcretici bilgisi ve imza bilgileri do\u011fru ve g\u00fcncel olmal\u0131d\u0131r.\n            <\/p>\n          <\/div>\n\n          <div class=\"kk-health-card\">\n            <h3>Teknik Dosya Tutarl\u0131l\u0131\u011f\u0131<\/h3>\n            <p>\n              \u00dcTS kayd\u0131, etiket, IFU, uygunluk beyan\u0131, risk analizi, GSPR tablosu ve katalog bilgileri birbirini desteklemelidir.\n            <\/p>\n          <\/div>\n        <\/div>\n      <\/section>\n\n      <section id=\"sgk\">\n        <h2>SGK ve Raporlu \u00dcr\u00fcn S\u00fcre\u00e7leri A\u00e7\u0131s\u0131ndan Olas\u0131 Etkiler<\/h2>\n\n        <p>\n          Sa\u011fl\u0131k raporlar\u0131 bir\u00e7ok medikal \u00fcr\u00fcn i\u00e7in SGK geri \u00f6deme s\u00fcre\u00e7lerinin temel dayanaklar\u0131ndan biridir. Raporlar\u0131n elektronik ve do\u011frulanabilir hale gelmesi; \u00fcr\u00fcn, rapor, re\u00e7ete, \u00dcTS kayd\u0131 ve barkod aras\u0131ndaki uyumu daha \u00f6nemli hale getirebilir.\n        <\/p>\n\n        <ul>\n          <li>Raporlar\u0131n do\u011frulanabilirli\u011fi artabilir.<\/li>\n          <li>Eksik veya hatal\u0131 raporlarla i\u015flem yap\u0131lmas\u0131 zorla\u015fabilir.<\/li>\n          <li>\u00dcr\u00fcn ihtiyac\u0131 ile temin edilen \u00fcr\u00fcn aras\u0131ndaki uyum daha fazla sorgulanabilir.<\/li>\n          <li>\u00dcTS kayd\u0131 ve \u00fcr\u00fcn barkodu daha kritik hale gelebilir.<\/li>\n          <li>Medikal firmalar\u0131n \u00fcr\u00fcn bilgilerini g\u00fcncel tutmas\u0131 gerekebilir.<\/li>\n          <li>T\u0131bbi malzeme kullan\u0131m raporlar\u0131 ile \u00fcr\u00fcn teknik bilgileri aras\u0131nda tutarl\u0131l\u0131k aranabilir.<\/li>\n        <\/ul>\n\n        <div class=\"kk-health-highlight\">\n          <strong>Medikal firma a\u00e7\u0131s\u0131ndan sonu\u00e7:<\/strong> Raporlu \u00fcr\u00fcnlerde sadece sat\u0131\u015f de\u011fil; do\u011fru \u00fcr\u00fcn kayd\u0131, do\u011fru barkod, do\u011fru teknik dosya ve do\u011fru etiketleme bir b\u00fct\u00fcn olarak y\u00f6netilmelidir.\n        <\/div>\n      <\/section>\n\n      <section id=\"kontrol-listesi\">\n        <h2>T\u0131bbi Cihaz Firmalar\u0131 \u0130\u00e7in Pratik Kontrol Listesi<\/h2>\n\n        <p>\n          A\u015fa\u011f\u0131daki liste, sa\u011fl\u0131k raporu ile ili\u015fkili \u00fcr\u00fcnlerde \u00dcTS, teknik dosya, etiket ve belgelendirme uyumunu h\u0131zl\u0131ca kontrol etmek i\u00e7in kullan\u0131labilir.\n        <\/p>\n\n        <div class=\"kk-health-table-wrap\">\n          <table class=\"kk-health-table\">\n            <thead>\n              <tr>\n                <th>Kontrol Alan\u0131<\/th>\n                <th>Kontrol Sorusu<\/th>\n                <th>Durum<\/th>\n              <\/tr>\n            <\/thead>\n            <tbody>\n              <tr>\n                <td>\u00dcTS Kayd\u0131<\/td>\n                <td>T\u00fcm \u00fcr\u00fcnler do\u011fru \u00fcr\u00fcn ad\u0131, marka, model ve barkod ile \u00dcTS\u2019de kay\u0131tl\u0131 m\u0131?<\/td>\n                <td>\u2610<\/td>\n              <\/tr>\n              <tr>\n                <td>Barkod \/ UDI<\/td>\n                <td>Her \u00fcr\u00fcn varyant\u0131n\u0131n barkod, GTIN, UDI-DI veya Basic UDI-DI bilgisi do\u011fru mu?<\/td>\n                <td>\u2610<\/td>\n              <\/tr>\n              <tr>\n                <td>Teknik Dosya<\/td>\n                <td>Kullan\u0131m amac\u0131, hedef hasta grubu ve \u00fcr\u00fcn tan\u0131m\u0131 g\u00fcncel mi?<\/td>\n                <td>\u2610<\/td>\n              <\/tr>\n              <tr>\n                <td>Risk Analizi<\/td>\n                <td>Yanl\u0131\u015f kullan\u0131m, yanl\u0131\u015f beden se\u00e7imi ve hasta g\u00fcvenli\u011fi riskleri de\u011ferlendirildi mi?<\/td>\n                <td>\u2610<\/td>\n              <\/tr>\n              <tr>\n                <td>Etiket<\/td>\n                <td>Etiket bilgileri \u00dcTS ve teknik dosya ile uyumlu mu?<\/td>\n                <td>\u2610<\/td>\n              <\/tr>\n              <tr>\n                <td>Kullan\u0131m Talimat\u0131<\/td>\n                <td>IFU hasta, hasta yak\u0131n\u0131 veya sa\u011fl\u0131k personeli taraf\u0131ndan anla\u015f\u0131l\u0131r m\u0131?<\/td>\n                <td>\u2610<\/td>\n              <\/tr>\n              <tr>\n                <td>Uygunluk Beyan\u0131<\/td>\n                <td>\u00dcr\u00fcn kapsam\u0131, risk s\u0131n\u0131f\u0131 ve standart bilgileri do\u011fru yaz\u0131lm\u0131\u015f m\u0131?<\/td>\n                <td>\u2610<\/td>\n              <\/tr>\n              <tr>\n                <td>Web \/ Katalog<\/td>\n                <td>Tan\u0131t\u0131m metinleri teknik dosya iddialar\u0131yla uyumlu mu?<\/td>\n                <td>\u2610<\/td>\n              <\/tr>\n              <tr>\n                <td>Raporlu \u00dcr\u00fcnler<\/td>\n                <td>\u00dcr\u00fcn sa\u011fl\u0131k raporu, re\u00e7ete veya SGK s\u00fcrecine konu oluyorsa belge uyumu ayr\u0131ca kontrol edildi mi?<\/td>\n                <td>\u2610<\/td>\n              <\/tr>\n            <\/tbody>\n          <\/table>\n        <\/div>\n\n        <div class=\"kk-health-warning\">\n          <strong>En s\u0131k g\u00f6r\u00fclen hata:<\/strong> \u00dcTS\u2019deki \u00fcr\u00fcn ad\u0131, etiketteki \u00fcr\u00fcn ad\u0131, uygunluk beyan\u0131 ve teknik dosya kapsam\u0131n\u0131n birbirinden farkl\u0131 olmas\u0131d\u0131r. Bu durum denetimlerde ciddi uyumsuzluk riski olu\u015fturabilir.\n        <\/div>\n      <\/section>\n\n      <section>\n        <h2>Firmalar \u015eimdi Ne Yapmal\u0131?<\/h2>\n\n        <ol>\n          <li>Sa\u011fl\u0131k raporu ile ili\u015fkili \u00fcr\u00fcn gruplar\u0131n\u0131 belirleyin.<\/li>\n          <li>\u00dcTS \u00fcr\u00fcn kay\u0131tlar\u0131n\u0131 ve barkod bilgilerini kontrol edin.<\/li>\n          <li>Teknik dosyada kullan\u0131m amac\u0131 ve hasta grubu tan\u0131mlar\u0131n\u0131 g\u00f6zden ge\u00e7irin.<\/li>\n          <li>Risk analizinde hasta kullan\u0131m senaryolar\u0131n\u0131 de\u011ferlendirin.<\/li>\n          <li>Etiket ve kullan\u0131m talimatlar\u0131n\u0131 teknik dosya ile kar\u015f\u0131la\u015ft\u0131r\u0131n.<\/li>\n          <li>Uygunluk beyan\u0131, katalog ve web sitesi a\u00e7\u0131klamalar\u0131n\u0131 uyumlu hale getirin.<\/li>\n          <li>SGK veya rapora ba\u011fl\u0131 temin edilen \u00fcr\u00fcnler i\u00e7in ek belge kontrol\u00fc yap\u0131n.<\/li>\n        <\/ol>\n\n        <div class=\"kk-health-success\">\n          <strong>F\u0131rsat:<\/strong> Belge d\u00fczeni g\u00fc\u00e7l\u00fc, \u00dcTS kay\u0131tlar\u0131 do\u011fru ve teknik dosyas\u0131 g\u00fcncel olan firmalar; hastaneler, bayiler, kamu kurumlar\u0131 ve denet\u00e7iler nezdinde daha g\u00fcvenilir g\u00f6r\u00fcn\u00fcr.\n        <\/div>\n      <\/section>\n\n      <section>\n        <h2>KaliteKit Bu S\u00fcre\u00e7te Nas\u0131l Destek Sa\u011flar?<\/h2>\n\n        <p>\n          KaliteKit olarak t\u0131bbi cihaz firmalar\u0131na \u00dcTS kay\u0131t s\u00fcreci, MDR teknik dosya haz\u0131rl\u0131\u011f\u0131, risk analizi, etiket ve kullan\u0131m talimat\u0131 kontrol\u00fc, uygunluk beyan\u0131, GSPR tablosu ve belgelendirme s\u00fcre\u00e7lerinde profesyonel destek sa\u011fl\u0131yoruz.\n        <\/p>\n\n        <div class=\"kk-health-cta\">\n          <h2>\u00dcTS, Teknik Dosya ve Etiket Uyumunuzu Kontrol Ettirin<\/h2>\n          <p>\n            Sa\u011fl\u0131k raporu ile ili\u015fkili \u00fcr\u00fcnlerinizin \u00dcTS kayd\u0131, teknik dosyas\u0131, etiketi ve kullan\u0131m talimat\u0131 birbiriyle uyumlu mu? \u00dcr\u00fcnlerinizi denetime haz\u0131r hale getirmek i\u00e7in \u00f6n de\u011ferlendirme talep edebilirsiniz.\n          <\/p>\n          <a href=\"\/iletisim\/\">\u00dccretsiz \u00d6n De\u011ferlendirme Talep Edin<\/a>\n        <\/div>\n      <\/section>\n\n      <section id=\"sss\" class=\"kk-health-faq\">\n        <h2>S\u0131k Sorulan Sorular<\/h2>\n\n        <details>\n          <summary>Sa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi t\u0131bbi cihaz firmalar\u0131na yeni bir zorunluluk getiriyor mu?<\/summary>\n          <p>\n            Y\u00f6netmelik do\u011frudan t\u0131bbi cihaz teknik dosyas\u0131 veya CE belgelendirme zorunlulu\u011fu getirmez. Ancak sa\u011fl\u0131k raporlar\u0131n\u0131n dijitalle\u015fmesi, t\u0131bbi cihazlar\u0131n rapor, re\u00e7ete, \u00dcTS ve SGK s\u00fcre\u00e7leriyle olan ba\u011flant\u0131s\u0131n\u0131 daha \u00f6nemli hale getirir.\n          <\/p>\n        <\/details>\n\n        <details>\n          <summary>e-Nab\u0131z \u00fczerinden sa\u011fl\u0131k raporu ba\u015fvurusu t\u0131bbi cihaz firmalar\u0131n\u0131 ilgilendirir mi?<\/summary>\n          <p>\n            Dolayl\u0131 olarak evet. Rapor s\u00fcre\u00e7lerinin dijitalle\u015fmesi, rapora ba\u011fl\u0131 temin edilen \u00fcr\u00fcnlerde \u00fcr\u00fcn bilgisi, barkod, \u00dcTS kayd\u0131 ve teknik dosya tutarl\u0131l\u0131\u011f\u0131n\u0131 daha \u00f6nemli hale getirir.\n          <\/p>\n        <\/details>\n\n        <details>\n          <summary>\u00dcTS kay\u0131tlar\u0131 bu y\u00f6netmelikten etkilenir mi?<\/summary>\n          <p>\n            \u00dcTS ayr\u0131 bir sistemdir. Ancak sa\u011fl\u0131k raporu ile ili\u015fkili \u00fcr\u00fcnlerde \u00dcTS bilgilerinin do\u011fru ve g\u00fcncel olmas\u0131 daha kritik hale gelir. \u00dcr\u00fcn ad\u0131, barkod, model, risk s\u0131n\u0131f\u0131 ve belge bilgileri tutarl\u0131 olmal\u0131d\u0131r.\n          <\/p>\n        <\/details>\n\n        <details>\n          <summary>Teknik dosyada de\u011fi\u015fiklik yapmak gerekir mi?<\/summary>\n          <p>\n            Her firma i\u00e7in otomatik bir de\u011fi\u015fiklik zorunlulu\u011fu yoktur. Ancak sa\u011fl\u0131k raporu ile temin edilen veya hasta kullan\u0131m\u0131na y\u00f6nelik \u00fcr\u00fcnlerde kullan\u0131m amac\u0131, risk analizi, etiket, IFU ve klinik gerek\u00e7elendirme b\u00f6l\u00fcmleri g\u00f6zden ge\u00e7irilmelidir.\n          <\/p>\n        <\/details>\n\n        <details>\n          <summary>Etiket ve kullan\u0131m talimat\u0131 neden \u00f6nemli?<\/summary>\n          <p>\n            Hasta, hasta yak\u0131n\u0131 veya sa\u011fl\u0131k personeli \u00fcr\u00fcn\u00fc etiket ve kullan\u0131m talimat\u0131ndaki bilgilere g\u00f6re kullan\u0131r. Eksik veya teknik dosya ile uyumsuz bilgiler hasta g\u00fcvenli\u011fi ve denetim a\u00e7\u0131s\u0131ndan risk olu\u015fturur.\n          <\/p>\n        <\/details>\n\n        <details>\n          <summary>SGK geri \u00f6deme s\u00fcre\u00e7lerinde etkisi olabilir mi?<\/summary>\n          <p>\n            Sa\u011fl\u0131k raporlar\u0131 bir\u00e7ok medikal \u00fcr\u00fcn\u00fcn geri \u00f6deme s\u00fcrecinde temel belge niteli\u011findedir. Raporlar\u0131n elektronik ve do\u011frulanabilir hale gelmesi; \u00fcr\u00fcn, rapor, re\u00e7ete ve \u00dcTS kayd\u0131 aras\u0131ndaki uyumu daha \u00f6nemli hale getirebilir.\n          <\/p>\n        <\/details>\n\n        <details>\n          <summary>\u0130ngilizce rapor deste\u011fi t\u0131bbi cihaz firmalar\u0131 i\u00e7in ne anlama gelir?<\/summary>\n          <p>\n            \u0130ngilizce rapor formatlar\u0131n\u0131n desteklenmesi, \u00f6zellikle uluslararas\u0131 kullan\u0131m, yurtd\u0131\u015f\u0131 tedavi s\u00fcre\u00e7leri veya yabanc\u0131 kurumlara sunulacak raporlarda standartla\u015fmay\u0131 art\u0131rabilir. Bu durum do\u011frudan t\u0131bbi cihaz teknik dosyas\u0131 zorunlulu\u011fu olu\u015fturmaz ancak belge standardizasyonu a\u00e7\u0131s\u0131ndan \u00f6nemlidir.\n          <\/p>\n        <\/details>\n      <\/section>\n\n      <section>\n        <h2>Sonu\u00e7<\/h2>\n\n        <p>\n          Sa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi, t\u0131bbi cihaz firmalar\u0131 i\u00e7in do\u011frudan yeni bir teknik dosya veya CE belgelendirme y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fc getirmese de, sa\u011fl\u0131k raporlar\u0131n\u0131n dijitalle\u015fmesi ve standartla\u015fmas\u0131 nedeniyle t\u0131bbi cihaz sekt\u00f6r\u00fcn\u00fc yak\u0131ndan ilgilendirir.\n        <\/p>\n\n        <p>\n          \u00d6zellikle sa\u011fl\u0131k raporu ile temin edilen, SGK s\u00fcre\u00e7lerine konu olan veya hasta kullan\u0131m\u0131na y\u00f6nelik \u00fcr\u00fcnlerde; \u00dcTS kayd\u0131, barkod y\u00f6netimi, teknik dosya, etiket, kullan\u0131m talimat\u0131 ve uygunluk beyan\u0131 aras\u0131ndaki tutarl\u0131l\u0131k daha \u00f6nemli hale gelmi\u015ftir.\n        <\/p>\n\n        <p>\n          Yeni d\u00f6nemde firmalar yaln\u0131zca \u00fcr\u00fcn sat\u0131\u015f\u0131 de\u011fil; \u00fcr\u00fcn\u00fcn kay\u0131t, belge, kullan\u0131m amac\u0131 ve izlenebilirlik zincirini de profesyonel \u015fekilde y\u00f6netmelidir.\n        <\/p>\n      <\/section>\n\n      <div class=\"kk-health-tags\">\n        <span>Sa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi<\/span>\n        <span>e-Nab\u0131z<\/span>\n        <span>e-Rapor<\/span>\n        <span>Sa\u011fl\u0131k Durum Belgesi<\/span>\n        <span>T\u0131bbi Cihaz<\/span>\n        <span>\u00dcTS Kayd\u0131<\/span>\n        <span>Teknik Dosya<\/span>\n        <span>Etiket ve IFU<\/span>\n        <span>SGK Medikal \u00dcr\u00fcn<\/span>\n        <span>MDR<\/span>\n        <span>ISO 13485<\/span>\n      <\/div>\n\n      <p class=\"kk-health-note\">\n        Bu yaz\u0131 genel bilgilendirme amac\u0131yla haz\u0131rlanm\u0131\u015ft\u0131r. Firma, \u00fcr\u00fcn s\u0131n\u0131f\u0131, kullan\u0131m amac\u0131, sa\u011fl\u0131k raporu ili\u015fkisi, \u00dcTS kayd\u0131 ve mevzuat kapsam\u0131na g\u00f6re teknik de\u011ferlendirme ayr\u0131ca yap\u0131lmal\u0131d\u0131r.\n      <\/p>\n\n    <\/main>\n  <\/div>\n<\/article>\n\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"Article\",\n  \"headline\": \"Sa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi T\u0131bbi Cihaz Firmalar\u0131n\u0131 Nas\u0131l Etkiler?\",\n  \"description\": \"Sa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi t\u0131bbi cihaz firmalar\u0131 i\u00e7in ne anlama geliyor? e-Nab\u0131z, e-Rapor, sa\u011fl\u0131k durum belgesi, \u00dcTS kayd\u0131, teknik dosya, etiket, IFU ve belgelendirme a\u00e7\u0131s\u0131ndan kapsaml\u0131 rehber.\",\n  \"author\": {\n    \"@type\": \"Organization\",\n    \"name\": \"KaliteKit\"\n  },\n  \"publisher\": {\n    \"@type\": \"Organization\",\n    \"name\": \"KaliteKit\"\n  },\n  \"mainEntityOfPage\": {\n    \"@type\": \"WebPage\",\n    \"@id\": \"https:\/\/www.kalitekit.com.tr\/saglik-raporlari-yonetmeligi-tibbi-cihaz-firmalarini-nasil-etkiler\/\"\n  },\n  \"inLanguage\": \"tr-TR\"\n}\n<\/script>\n\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"FAQPage\",\n  \"mainEntity\": [\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Sa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi t\u0131bbi cihaz firmalar\u0131na yeni bir zorunluluk getiriyor mu?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Y\u00f6netmelik do\u011frudan t\u0131bbi cihaz teknik dosyas\u0131 veya CE belgelendirme zorunlulu\u011fu getirmez. Ancak sa\u011fl\u0131k raporlar\u0131n\u0131n dijitalle\u015fmesi, t\u0131bbi cihazlar\u0131n rapor, re\u00e7ete, \u00dcTS ve SGK s\u00fcre\u00e7leriyle olan ba\u011flant\u0131s\u0131n\u0131 daha \u00f6nemli hale getirir.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"e-Nab\u0131z \u00fczerinden sa\u011fl\u0131k raporu ba\u015fvurusu t\u0131bbi cihaz firmalar\u0131n\u0131 ilgilendirir mi?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Dolayl\u0131 olarak evet. Rapor s\u00fcre\u00e7lerinin dijitalle\u015fmesi, rapora ba\u011fl\u0131 temin edilen \u00fcr\u00fcnlerde \u00fcr\u00fcn bilgisi, barkod, \u00dcTS kayd\u0131 ve teknik dosya tutarl\u0131l\u0131\u011f\u0131n\u0131 daha \u00f6nemli hale getirir.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"\u00dcTS kay\u0131tlar\u0131 bu y\u00f6netmelikten etkilenir mi?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"\u00dcTS ayr\u0131 bir sistemdir. Ancak sa\u011fl\u0131k raporu ile ili\u015fkili \u00fcr\u00fcnlerde \u00dcTS bilgilerinin do\u011fru ve g\u00fcncel olmas\u0131 daha kritik hale gelir. \u00dcr\u00fcn ad\u0131, barkod, model, risk s\u0131n\u0131f\u0131 ve belge bilgileri tutarl\u0131 olmal\u0131d\u0131r.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Teknik dosyada de\u011fi\u015fiklik yapmak gerekir mi?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Her firma i\u00e7in otomatik bir de\u011fi\u015fiklik zorunlulu\u011fu yoktur. Ancak sa\u011fl\u0131k raporu ile temin edilen veya hasta kullan\u0131m\u0131na y\u00f6nelik \u00fcr\u00fcnlerde kullan\u0131m amac\u0131, risk analizi, etiket, IFU ve klinik gerek\u00e7elendirme b\u00f6l\u00fcmleri g\u00f6zden ge\u00e7irilmelidir.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Etiket ve kullan\u0131m talimat\u0131 neden \u00f6nemli?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Hasta, hasta yak\u0131n\u0131 veya sa\u011fl\u0131k personeli \u00fcr\u00fcn\u00fc etiket ve kullan\u0131m talimat\u0131ndaki bilgilere g\u00f6re kullan\u0131r. Eksik veya teknik dosya ile uyumsuz bilgiler hasta g\u00fcvenli\u011fi ve denetim a\u00e7\u0131s\u0131ndan risk olu\u015fturur.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"SGK geri \u00f6deme s\u00fcre\u00e7lerinde etkisi olabilir mi?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Sa\u011fl\u0131k raporlar\u0131 bir\u00e7ok medikal \u00fcr\u00fcn\u00fcn geri \u00f6deme s\u00fcrecinde temel belge niteli\u011findedir. Raporlar\u0131n elektronik ve do\u011frulanabilir hale gelmesi; \u00fcr\u00fcn, rapor, re\u00e7ete ve \u00dcTS kayd\u0131 aras\u0131ndaki uyumu daha \u00f6nemli hale getirebilir.\"\n      }\n    }\n  ]\n}\n<\/script>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sa\u011fl\u0131k Raporlar\u0131 Y\u00f6netmeli\u011fi t\u0131bbi cihaz firmalar\u0131 i\u00e7in ne anlama geliyor? \u00dcTS kayd\u0131, teknik dosya, etiket, IFU, SGK ve belgelendirme a\u00e7\u0131s\u0131ndan kapsaml\u0131 rehber.<\/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-13874","post","type-post","status-publish","format-standard","hentry","category-blog"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/13874","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=13874"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/13874\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13874"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/categories?post=13874"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/tags?post=13874"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}