{"id":23677,"date":"2026-09-28T12:26:35","date_gmt":"2026-09-28T09:26:35","guid":{"rendered":"https:\/\/mirora.com\/?page_id=23677"},"modified":"2026-09-28T23:47:32","modified_gmt":"2026-09-28T20:47:32","slug":"tibbi-cihaz-cevirisi","status":"publish","type":"page","link":"https:\/\/mirora.com\/tr\/tibbi-cihaz-cevirisi\/","title":{"rendered":"T\u0131bbi Cihaz \u00c7evirisi"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"23677\" class=\"elementor elementor-23677\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-15f7d71 e-con-boxed mw-page mw-hero2 e-flex e-con e-parent\" data-id=\"15f7d71\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-e360397 e-grid e-con-full e-con e-child\" data-id=\"e360397\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-38b6307 e-con-full e-flex e-con e-child\" data-id=\"38b6307\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\r\n\r\n\t\t<div class=\"elementor-element elementor-element-01d0e0e mw-eyebrow elementor-widget elementor-widget-heading\" data-id=\"01d0e0e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Medikal \u00c7eviri Hizmetleri<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e09eeb2 mw-w760 elementor-widget elementor-widget-heading\" data-id=\"e09eeb2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">T\u0131bbi Cihaz \u00c7evirisi<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-43a6913 mw-w760 elementor-widget elementor-widget-text-editor\" data-id=\"43a6913\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>T\u0131bbi cihaz \u00e7evirisi, t\u0131bbi cihazlar\u0131n ve in vitro tan\u0131 (IVD) \u00fcr\u00fcnlerinin kullan\u0131m\u0131, etiketlenmesi ve reg\u00fclasyona uyumu i\u00e7in gereken belgeleri kapsar. Cihaz\u0131n kullan\u0131laca\u011f\u0131 \u00fclkenin diline do\u011fru ve mevzuata uygun \u00e7eviri, \u00e7o\u011fu pazarda yasal bir zorunluluktur; kullan\u0131m k\u0131lavuzundaki tek bir belirsiz talimat hem hasta hem kullan\u0131c\u0131 g\u00fcvenli\u011fini do\u011frudan etkileyebilir. A\u015fa\u011f\u0131da hangi belgelerin \u00e7evrildi\u011fini, hangi kurallara tabi olduklar\u0131n\u0131 ve \u00e7evirinin nelere dikkat etmesi gerekti\u011fini bulacaks\u0131n\u0131z.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5d731e6 mw-btn elementor-widget elementor-widget-button\" data-id=\"5d731e6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/tr\/teklif-al\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Teklif Al \u2192<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-dbb9e7d e-con-full e-flex e-con e-child\" data-id=\"dbb9e7d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-aeb4d7f e-con-full mw-left-accent e-flex e-con e-child\" data-id=\"aeb4d7f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bdedaef elementor-widget elementor-widget-heading\" data-id=\"bdedaef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">MDR<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0077061 elementor-widget elementor-widget-heading\" data-id=\"0077061\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">(AB) 2017\/745 \u00b7 T\u0131bbi Cihaz Y\u00f6netmeli\u011fi<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-21dbb61 e-con-full mw-left-accent e-flex e-con e-child\" data-id=\"21dbb61\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e92a9dc elementor-widget elementor-widget-heading\" data-id=\"e92a9dc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">IVDR<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9342285 elementor-widget elementor-widget-heading\" data-id=\"9342285\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">(AB) 2017\/746 \u00b7 \u0130n vitro tan\u0131 cihazlar\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8114dd9 e-con-full mw-left-accent e-flex e-con e-child\" data-id=\"8114dd9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6b92351 elementor-widget elementor-widget-heading\" data-id=\"6b92351\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">ISO 15223-1<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e2e4427 elementor-widget elementor-widget-heading\" data-id=\"e2e4427\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Etiket sembolleri standard\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-022b419 e-con-boxed mw-page e-flex e-con e-parent\" data-id=\"022b419\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f7e3cbe e-grid e-con-full e-con e-child\" data-id=\"f7e3cbe\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5bffe3c e-con-full e-flex e-con e-child\" data-id=\"5bffe3c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-991ccf0 mw-eyebrow elementor-widget elementor-widget-heading\" data-id=\"991ccf0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Mevzuat<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5ee8b0a mw-w820 elementor-widget elementor-widget-heading\" data-id=\"5ee8b0a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u00c7eviri neden zorunlu?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9341c33 elementor-widget elementor-widget-text-editor\" data-id=\"9341c33\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>T\u0131bbi cihaz mevzuat\u0131, g\u00fcvenli kullan\u0131m i\u00e7in gereken bilginin kullan\u0131c\u0131n\u0131n anlayaca\u011f\u0131 dilde sunulmas\u0131n\u0131 \u015fart ko\u015far. Avrupa Birli\u011fi&#8217;nde bu, cihaz\u0131n sat\u0131laca\u011f\u0131 her \u00fcye devletin resm\u00ee dilinde belge sunmak anlam\u0131na gelir; T\u00fcrkiye&#8217;de de Avrupa mevzuat\u0131yla uyumlu T\u0131bbi Cihaz Y\u00f6netmeli\u011fi uygulan\u0131r. \u00c7eviri bu y\u00fczden pazarlama sonras\u0131 bir ayr\u0131nt\u0131 de\u011fil, uygunluk (CE) s\u00fcrecinin ve pazara giri\u015f dosyas\u0131n\u0131n ayr\u0131lmaz bir par\u00e7as\u0131d\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1fc8ae7 e-con-full e-flex e-con e-child\" data-id=\"1fc8ae7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-c5b1adf e-con-full mw-left-accent e-flex e-con e-child\" data-id=\"c5b1adf\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8ea3c35 elementor-widget elementor-widget-heading\" data-id=\"8ea3c35\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">CE<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-16828de elementor-widget elementor-widget-heading\" data-id=\"16828de\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Avrupa uygunluk i\u015fareti<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e49bb0e e-con-full mw-left-accent e-flex e-con e-child\" data-id=\"e49bb0e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5d10a4d elementor-widget elementor-widget-heading\" data-id=\"5d10a4d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">UDI<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2a409d5 elementor-widget elementor-widget-heading\" data-id=\"2a409d5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Cihaz\u0131n benzersiz kimlik numaras\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a658099 e-con-full mw-left-accent e-flex e-con e-child\" data-id=\"a658099\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc9d860 elementor-widget elementor-widget-heading\" data-id=\"dc9d860\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">MDR \/ IVDR<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-afa4756 elementor-widget elementor-widget-heading\" data-id=\"afa4756\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Belgelerin her \u00fcye devletin resm\u00ee dilinde sunulmas\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-feefa10 e-con-boxed mw-page e-flex e-con e-parent\" data-id=\"feefa10\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-055b46c mw-eyebrow elementor-widget elementor-widget-heading\" data-id=\"055b46c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Kapsam\u0131m\u0131z<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f0dcc53 mw-w820 elementor-widget elementor-widget-heading\" data-id=\"f0dcc53\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Ba\u015fl\u0131ca belge t\u00fcrleri<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-822e98f mw-w820 elementor-widget elementor-widget-text-editor\" data-id=\"822e98f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>T\u0131bbi cihaz dok\u00fcmantasyonu, cihaz\u0131 kullanan ki\u015fiden d\u00fczenleyiciye kadar farkl\u0131 okuyuculara hitap eder.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e9e20ad e-grid e-con-full e-con e-child\" data-id=\"e9e20ad\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-efc4ffb e-con-full mw-hover e-flex e-con e-child\" data-id=\"efc4ffb\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1a7bb3d elementor-widget elementor-widget-heading\" data-id=\"1a7bb3d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">01<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-66ac8ba elementor-widget elementor-widget-heading\" data-id=\"66ac8ba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Kullan\u0131m k\u0131lavuzu (IFU)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-08fb911 elementor-widget elementor-widget-text-editor\" data-id=\"08fb911\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Kullan\u0131m k\u0131lavuzu, cihaz\u0131n g\u00fcvenli ve do\u011fru kullan\u0131m\u0131n\u0131 anlatan en kritik belgedir: kullan\u0131m amac\u0131, uyar\u0131lar, kontrendikasyonlar, ad\u0131m ad\u0131m i\u015flemler ve bak\u0131m talimatlar\u0131 burada yer al\u0131r. \u00c7evirisi teknik olarak do\u011fru ve terminolojik olarak tutarl\u0131 olmal\u0131, ancak hedef kullan\u0131c\u0131n\u0131n (hekim, hem\u015fire, hasta) d\u00fczeyine uygun bir dille yaz\u0131lmal\u0131d\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-08c4ab8 e-con-full mw-hover e-flex e-con e-child\" data-id=\"08c4ab8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1f54442 elementor-widget elementor-widget-heading\" data-id=\"1f54442\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">02<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7b90fa3 elementor-widget elementor-widget-heading\" data-id=\"7b90fa3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Etiket ve semboller<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b93e86 elementor-widget elementor-widget-text-editor\" data-id=\"4b93e86\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Etiketler s\u0131n\u0131rl\u0131 alanda zorunlu bilgileri ta\u015f\u0131r; bu y\u00fczden b\u00fcy\u00fck \u00f6l\u00e7\u00fcde standart sembollere dayan\u0131r. T\u0131bbi cihaz etiketlerinde kullan\u0131lan semboller ISO 15223-1 standard\u0131nda tan\u0131mlan\u0131r ve \u00e7o\u011fu \u00fclkede metin yerine ge\u00e7er. \u00c7evirmenin hangi bilginin sembolle, hangisinin metinle verildi\u011fini bilmesi ve tek bir tutars\u0131zl\u0131k bile yaratmamas\u0131 gerekir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-985c91e e-con-full mw-hover e-flex e-con e-child\" data-id=\"985c91e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cc9e20d elementor-widget elementor-widget-heading\" data-id=\"cc9e20d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">03<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-91c73a0 elementor-widget elementor-widget-heading\" data-id=\"91c73a0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Yaz\u0131l\u0131m ve kullan\u0131c\u0131 aray\u00fcz\u00fc (UI)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b29271b elementor-widget elementor-widget-text-editor\" data-id=\"b29271b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Cihaz yaz\u0131l\u0131m\u0131 ve ekran metinleri k\u0131sa, alan s\u0131n\u0131rl\u0131 ve ba\u011flama ba\u011fl\u0131d\u0131r. Bir men\u00fc \u00f6\u011fesinin ya da uyar\u0131n\u0131n yanl\u0131\u015f ya da uzun \u00e7evrilmesi ekrana s\u0131\u011fmayabilir veya kullan\u0131c\u0131y\u0131 yan\u0131ltabilir. Bu y\u00fczden aray\u00fcz \u00e7evirisi, metinlerin ger\u00e7ek ekranda ba\u011flam i\u00e7inde kontrol edilmesini gerektirir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8b18623 e-con-full mw-hover e-flex e-con e-child\" data-id=\"8b18623\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3ed046f elementor-widget elementor-widget-heading\" data-id=\"3ed046f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">04<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8a9bec2 elementor-widget elementor-widget-heading\" data-id=\"8a9bec2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Teknik dosya, uygunluk beyan\u0131 ve klinik de\u011ferlendirme<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0bb6a46 elementor-widget elementor-widget-text-editor\" data-id=\"0bb6a46\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Teknik dosya, cihaz\u0131n mevzuata uygunlu\u011funu kan\u0131tlayan belgelerin b\u00fct\u00fcn\u00fcd\u00fcr; uygunluk beyan\u0131 \u00fcreticinin resm\u00ee taahh\u00fcd\u00fc, klinik de\u011ferlendirme ise g\u00fcvenlik ve performans kan\u0131t\u0131d\u0131r. Bu belgeler d\u00fczenleyiciye ve onaylanm\u0131\u015f kurulu\u015fa y\u00f6neliktir; \u00e7evirileri kesin, tutarl\u0131 ve kaynakla birebir izlenebilir olmal\u0131d\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9222d5d e-con-full mw-hover e-flex e-con e-child\" data-id=\"9222d5d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6a0c83a elementor-widget elementor-widget-heading\" data-id=\"6a0c83a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">05<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-612450f elementor-widget elementor-widget-heading\" data-id=\"612450f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">E\u011fitim ve pazarlama materyalleri<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-83d91f0 elementor-widget elementor-widget-text-editor\" data-id=\"83d91f0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Kullan\u0131c\u0131 e\u011fitimleri ve pazarlama i\u00e7erikleri daha serbest bir dil kullan\u0131r, ancak s\u0131n\u0131r\u0131 vard\u0131r: cihazla ilgili her iddia, onaylanm\u0131\u015f kullan\u0131m amac\u0131yla ve teknik dosyayla tutarl\u0131 olmak zorundad\u0131r. Pazarlama metnindeki abart\u0131l\u0131 bir ifade, reg\u00fclasyon a\u00e7\u0131s\u0131ndan sorun yaratabilir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fad4885 e-con-boxed mw-page e-flex e-con e-parent\" data-id=\"fad4885\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d40c630 mw-eyebrow elementor-widget elementor-widget-heading\" data-id=\"d40c630\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Reg\u00fclasyon<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d7ff70e mw-w820 elementor-widget elementor-widget-heading\" data-id=\"d7ff70e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Reg\u00fclasyon \u00e7er\u00e7eveleri (MDR \/ IVDR)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-39b3c6d mw-w820 elementor-widget elementor-widget-text-editor\" data-id=\"39b3c6d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Avrupa&#8217;da t\u0131bbi cihazlar T\u0131bbi Cihaz Y\u00f6netmeli\u011fi (MDR \u2014 (AB) 2017\/745), in vitro tan\u0131 cihazlar\u0131 ise IVDR ((AB) 2017\/746) kapsam\u0131ndad\u0131r. Bu \u00e7er\u00e7eveler, bir\u00e7ok belgenin cihaz\u0131n sat\u0131laca\u011f\u0131 her AB \u00fcye devletinin resm\u00ee dilinde sunulmas\u0131n\u0131 zorunlu k\u0131lar; cihazlar\u0131n benzersiz kimliklendirmesi (UDI) ve piyasaya arz sonras\u0131 g\u00f6zetim de ayn\u0131 mevzuat\u0131n par\u00e7as\u0131d\u0131r. Do\u011fru ve tutarl\u0131 \u00e7eviri bu y\u00fczden CE uygunluk s\u00fcrecinin ayr\u0131lmaz bir par\u00e7as\u0131d\u0131r.<\/p>\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<div class=\"elementor-element elementor-element-e9261a8 e-con-boxed mw-page e-flex e-con e-parent\" data-id=\"e9261a8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-89e0992 e-grid e-con-full e-con e-child\" data-id=\"89e0992\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-bf324e1 e-con-full e-flex e-con e-child\" data-id=\"bf324e1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8dad991 mw-eyebrow elementor-widget elementor-widget-heading\" data-id=\"8dad991\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Kalite Y\u00f6netimi<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-560e544 mw-w820 elementor-widget elementor-widget-heading\" data-id=\"560e544\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Kalite ve terminoloji<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a7f2236 elementor-widget elementor-widget-text-editor\" data-id=\"a7f2236\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>T\u0131bbi cihaz metinleri hem teknik hem reg\u00fclasyona tabi oldu\u011fundan, terminoloji y\u00f6netimi ve tutarl\u0131l\u0131k esast\u0131r; kullan\u0131c\u0131 g\u00fcvenli\u011fini etkileyen bir talimatta anlam belirsizli\u011fine yer yoktur. \u0130yi bir s\u00fcre\u00e7 \u00e7eviri belle\u011fine, onayl\u0131 s\u00f6zl\u00fcklere ve ba\u011f\u0131ms\u0131z bir edit\u00f6r\u00fcn redaksiyonuna dayan\u0131r; gerekti\u011finde back-translation de eklenir. Aray\u00fcz metinlerinde ayr\u0131ca ba\u011flam i\u00e7i kontrol yap\u0131l\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e772eac e-con-full e-flex e-con e-child\" data-id=\"e772eac\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fc35869 elementor-view-stacked elementor-shape-circle elementor-position-inline-start elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"fc35869\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\t\u00c7eviri belle\u011fi\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba85d13 elementor-view-stacked elementor-shape-circle elementor-position-inline-start elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"ba85d13\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tOnayl\u0131 s\u00f6zl\u00fckler\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af93e4c elementor-view-stacked elementor-shape-circle elementor-position-inline-start elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"af93e4c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tBa\u011f\u0131ms\u0131z edit\u00f6r redaksiyonu\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18b834c elementor-view-stacked elementor-shape-circle elementor-position-inline-start elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"18b834c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tBack-translation\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bb0e8ee elementor-view-stacked elementor-shape-circle elementor-position-inline-start elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"bb0e8ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tBa\u011flam i\u00e7i aray\u00fcz kontrol\u00fc\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9b8429b e-con-boxed mw-page e-flex e-con e-parent\" data-id=\"9b8429b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-10602e6 e-con-full mw-left-accent e-flex e-con e-child\" data-id=\"10602e6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c463ff6 elementor-widget elementor-widget-heading\" data-id=\"c463ff6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">S\u0131k yap\u0131lan hatalar<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7832cb6 elementor-widget elementor-widget-text-editor\" data-id=\"7832cb6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>En \u00e7ok kar\u015f\u0131la\u015f\u0131lan sorunlar \u015funlard\u0131r: kullan\u0131m k\u0131lavuzu ile etiket aras\u0131nda farkl\u0131 terim kullanmak; aray\u00fcz metinlerini ekran s\u0131n\u0131r\u0131n\u0131 g\u00f6zetmeden \u00e7evirmek ve kesilmesine yol a\u00e7mak; sembolle verilen bilgiyi ayr\u0131ca metne \u00e7evirerek \u00e7eli\u015fki yaratmak, pazarlama metninde onayl\u0131 kullan\u0131m amac\u0131n\u0131 a\u015fan iddialar kullanmak, cihaz tasar\u0131m\u0131 g\u00fcncellendi\u011finde \u00e7evirileri g\u00fcncellememek. Her biri g\u00fcvenlik riski ya da uygunluk sorunu do\u011furur.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5912e24 e-con-boxed mw-page e-flex e-con e-parent\" data-id=\"5912e24\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c7c8ac1 mw-eyebrow elementor-widget elementor-widget-heading\" data-id=\"c7c8ac1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Terminoloji<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3855bcc mw-w820 elementor-widget elementor-widget-heading\" data-id=\"3855bcc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">K\u0131sa terim s\u00f6zl\u00fc\u011f\u00fc<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-59eddbd e-grid e-con-full e-con e-child\" data-id=\"59eddbd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-07ed047 e-con-full e-flex e-con e-child\" data-id=\"07ed047\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f4f05cb elementor-widget elementor-widget-heading\" data-id=\"f4f05cb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">IFU<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5d6bfdf elementor-widget elementor-widget-heading\" data-id=\"5d6bfdf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Kullan\u0131m k\u0131lavuzu.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9145240 e-con-full e-flex e-con e-child\" data-id=\"9145240\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b40c0c9 elementor-widget elementor-widget-heading\" data-id=\"b40c0c9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">MDR \/ IVDR<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec03f03 elementor-widget elementor-widget-heading\" data-id=\"ec03f03\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Avrupa t\u0131bbi cihaz ve in vitro tan\u0131 cihaz\u0131 y\u00f6netmelikleri.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ca39d68 e-con-full e-flex e-con e-child\" data-id=\"ca39d68\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9d98803 elementor-widget elementor-widget-heading\" data-id=\"9d98803\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">CE<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ddd146e elementor-widget elementor-widget-heading\" data-id=\"ddd146e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Avrupa uygunluk i\u015fareti.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f1a049f e-con-full e-flex e-con e-child\" data-id=\"f1a049f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2adc3af elementor-widget elementor-widget-heading\" data-id=\"2adc3af\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">UDI<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7d0ca70 elementor-widget elementor-widget-heading\" data-id=\"7d0ca70\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Cihaz\u0131n benzersiz kimlik numaras\u0131.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9174e3b e-con-full e-flex e-con e-child\" data-id=\"9174e3b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a73f800 elementor-widget elementor-widget-heading\" data-id=\"a73f800\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Teknik dosya<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b0f01c5 elementor-widget elementor-widget-heading\" data-id=\"b0f01c5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Uygunlu\u011fu kan\u0131tlayan belge b\u00fct\u00fcn\u00fc.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f3441ef e-con-full e-flex e-con e-child\" data-id=\"f3441ef\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a0ba948 elementor-widget elementor-widget-heading\" data-id=\"a0ba948\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Uygunluk beyan\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d568a4d elementor-widget elementor-widget-heading\" data-id=\"d568a4d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">\u00dcreticinin resm\u00ee uygunluk taahh\u00fcd\u00fc.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-882c00b e-con-full e-flex e-con e-child\" data-id=\"882c00b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f2734b5 elementor-widget elementor-widget-heading\" data-id=\"f2734b5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Onaylanm\u0131\u015f kurulu\u015f<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0937ee6 elementor-widget elementor-widget-heading\" data-id=\"0937ee6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Uygunlu\u011fu de\u011ferlendiren ba\u011f\u0131ms\u0131z kurum.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b8114be e-con-full e-flex e-con e-child\" data-id=\"b8114be\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ec2d16f elementor-widget elementor-widget-heading\" data-id=\"ec2d16f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">ISO 15223-1<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-995bea1 elementor-widget elementor-widget-heading\" data-id=\"995bea1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Etiket sembolleri standard\u0131.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-32dbbcf e-con-boxed mw-page e-flex e-con e-parent\" data-id=\"32dbbcf\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4955060 e-con-full mw-exp e-flex e-con e-child\" data-id=\"4955060\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7d7034d mw-eyebrow elementor-widget elementor-widget-heading\" data-id=\"7d7034d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Mirora<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fda72f9 mw-w760 elementor-widget elementor-widget-heading\" data-id=\"fda72f9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Deneyim ve s\u00fcre\u00e7<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a0a7ad0 mw-w760 elementor-widget elementor-widget-text-editor\" data-id=\"a0a7ad0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Otuz y\u0131l\u0131 a\u015fk\u0131n s\u00fcredir medikal \u00e7eviride uzmanla\u015fan Mirora, ISO 9001 belgeli ve ISO 17100 ile uyumlu i\u015f ak\u0131\u015f\u0131yla t\u0131bbi cihaz \u00fcreticilerinin g\u00fcvendi\u011fi bir \u00e7eviri orta\u011f\u0131d\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-349664a e-con-boxed mw-page e-flex e-con e-parent\" data-id=\"349664a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0886320 mw-eyebrow elementor-widget elementor-widget-heading\" data-id=\"0886320\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">SSS<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0678294 mw-w820 elementor-widget elementor-widget-heading\" data-id=\"0678294\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">S\u0131k Sorulan Sorular<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-446b44b e-con-full mw-w900 e-flex e-con e-child\" data-id=\"446b44b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ab63b59 elementor-widget elementor-widget-n-accordion\" data-id=\"ab63b59\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1790\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1790\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> T\u0131bbi cihaz \u00e7evirisi neden zorunludur? <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1790\" class=\"elementor-element elementor-element-1376ab5 e-con-full e-flex e-con e-child\" data-id=\"1376ab5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4d55389 elementor-widget elementor-widget-text-editor\" data-id=\"4d55389\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Mevzuat, g\u00fcvenli kullan\u0131m i\u00e7in gereken bilginin kullan\u0131c\u0131n\u0131n dilinde sunulmas\u0131n\u0131 \u015fart ko\u015far; bu, uygunluk s\u00fcrecinin par\u00e7as\u0131d\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1791\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1791\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> MDR ve IVDR ne anlama gelir? <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1791\" class=\"elementor-element elementor-element-a157e85 e-con-full e-flex e-con e-child\" data-id=\"a157e85\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-87bdcef elementor-widget elementor-widget-text-editor\" data-id=\"87bdcef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>MDR Avrupa T\u0131bbi Cihaz Y\u00f6netmeli\u011fi, IVDR ise in vitro tan\u0131 cihazlar\u0131na ili\u015fkin y\u00f6netmeliktir; ikisi de belgelerin ilgili resm\u00ee dillerde sunulmas\u0131n\u0131 gerektirir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1792\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1792\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Hangi belgeler \u00e7evrilir? <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1792\" class=\"elementor-element elementor-element-db61caf e-con-full e-flex e-con e-child\" data-id=\"db61caf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a6c08c1 elementor-widget elementor-widget-text-editor\" data-id=\"a6c08c1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Kullan\u0131m k\u0131lavuzlar\u0131 (IFU), etiketler, cihaz yaz\u0131l\u0131m\u0131 ve aray\u00fcz\u00fc, teknik dosya, uygunluk beyan\u0131, klinik de\u011ferlendirme ile e\u011fitim ve pazarlama materyalleri.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1793\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1793\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Etiketlerdeki semboller \u00e7evrilir mi? <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1793\" class=\"elementor-element elementor-element-8766e62 e-con-full e-flex e-con e-child\" data-id=\"8766e62\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-81ba7e4 elementor-widget elementor-widget-text-editor\" data-id=\"81ba7e4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>ISO 15223-1 standard\u0131ndaki semboller \u00e7o\u011fu \u00fclkede metin yerine ge\u00e7er ve \u00e7evrilmez; hangi bilginin sembolle, hangisinin metinle verildi\u011fi bilinmeli ve tutarl\u0131l\u0131k korunmal\u0131d\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1794\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1794\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Cihaz yaz\u0131l\u0131m\u0131 ve aray\u00fcz \u00e7evirisinde ne de\u011fi\u015fir? <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1794\" class=\"elementor-element elementor-element-4a37c2c e-con-full e-flex e-con e-child\" data-id=\"4a37c2c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c075c36 elementor-widget elementor-widget-text-editor\" data-id=\"c075c36\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Metinler s\u0131n\u0131rl\u0131 alana s\u0131\u011fmal\u0131 ve kullan\u0131c\u0131y\u0131 yan\u0131ltmamal\u0131d\u0131r; bu y\u00fczden ba\u011flam i\u00e7inde, ger\u00e7ek ekranda kontrol gerekir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1795\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"6\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1795\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Terminoloji tutarl\u0131l\u0131\u011f\u0131 neden \u00f6nemlidir? <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1795\" class=\"elementor-element elementor-element-61b3227 e-con-full e-flex e-con e-child\" data-id=\"61b3227\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7891818 elementor-widget elementor-widget-text-editor\" data-id=\"7891818\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Ayn\u0131 cihaz\u0131n t\u00fcm belgelerinde tutarl\u0131 terim kullan\u0131m\u0131 hem kullan\u0131c\u0131 g\u00fcvenli\u011fi hem mevzuata uyum i\u00e7in gereklidir; onayl\u0131 s\u00f6zl\u00fck ve \u00e7eviri belle\u011fiyle sa\u011flan\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"T\\u0131bbi cihaz \\u00e7evirisi neden zorunludur?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Mevzuat, g\\u00fcvenli kullan\\u0131m i\\u00e7in gereken bilginin kullan\\u0131c\\u0131n\\u0131n dilinde sunulmas\\u0131n\\u0131 \\u015fart ko\\u015far; bu, uygunluk s\\u00fcrecinin par\\u00e7as\\u0131d\\u0131r.\"}},{\"@type\":\"Question\",\"name\":\"MDR ve IVDR ne anlama gelir?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"MDR Avrupa T\\u0131bbi Cihaz Y\\u00f6netmeli\\u011fi, IVDR ise in vitro tan\\u0131 cihazlar\\u0131na ili\\u015fkin y\\u00f6netmeliktir; ikisi de belgelerin ilgili resm\\u00ee dillerde sunulmas\\u0131n\\u0131 gerektirir.\"}},{\"@type\":\"Question\",\"name\":\"Hangi belgeler \\u00e7evrilir?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Kullan\\u0131m k\\u0131lavuzlar\\u0131 (IFU), etiketler, cihaz yaz\\u0131l\\u0131m\\u0131 ve aray\\u00fcz\\u00fc, teknik dosya, uygunluk beyan\\u0131, klinik de\\u011ferlendirme ile e\\u011fitim ve pazarlama materyalleri.\"}},{\"@type\":\"Question\",\"name\":\"Etiketlerdeki semboller \\u00e7evrilir mi?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"ISO 15223-1 standard\\u0131ndaki semboller \\u00e7o\\u011fu \\u00fclkede metin yerine ge\\u00e7er ve \\u00e7evrilmez; hangi bilginin sembolle, hangisinin metinle verildi\\u011fi bilinmeli ve tutarl\\u0131l\\u0131k korunmal\\u0131d\\u0131r.\"}},{\"@type\":\"Question\",\"name\":\"Cihaz yaz\\u0131l\\u0131m\\u0131 ve aray\\u00fcz \\u00e7evirisinde ne de\\u011fi\\u015fir?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Metinler s\\u0131n\\u0131rl\\u0131 alana s\\u0131\\u011fmal\\u0131 ve kullan\\u0131c\\u0131y\\u0131 yan\\u0131ltmamal\\u0131d\\u0131r; bu y\\u00fczden ba\\u011flam i\\u00e7inde, ger\\u00e7ek ekranda kontrol gerekir.\"}},{\"@type\":\"Question\",\"name\":\"Terminoloji tutarl\\u0131l\\u0131\\u011f\\u0131 neden \\u00f6nemlidir?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Ayn\\u0131 cihaz\\u0131n t\\u00fcm belgelerinde tutarl\\u0131 terim kullan\\u0131m\\u0131 hem kullan\\u0131c\\u0131 g\\u00fcvenli\\u011fi hem mevzuata uyum i\\u00e7in gereklidir; onayl\\u0131 s\\u00f6zl\\u00fck ve \\u00e7eviri belle\\u011fiyle sa\\u011flan\\u0131r.\"}}]}<\/script>\n\t\t\t\t\t\t\t<\/div>\n\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>Medikal \u00c7eviri Hizmetleri T\u0131bbi Cihaz \u00c7evirisi T\u0131bbi cihaz \u00e7evirisi, t\u0131bbi cihazlar\u0131n ve in vitro tan\u0131 (IVD) \u00fcr\u00fcnlerinin kullan\u0131m\u0131, etiketlenmesi ve&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-23677","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>T\u0131bbi Cihaz \u00c7evirisi Nedir? 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