MDR alt\u0131nda klinik de\u011ferlendirme, sadece y\u00fcksek s\u0131n\u0131f cihazlar i\u00e7in de\u011fil t\u00fcm t\u0131bbi cihazlar i\u00e7in g\u00fcvenlik ve performans kan\u0131t\u0131n\u0131n bir par\u00e7as\u0131d\u0131r. Literat\u00fcr, e\u015fde\u011fer cihaz, klinik deneyim, PMS\/PMCF verileri ve gerekirse klinik ara\u015ft\u0131rma sonu\u00e7lar\u0131 kullan\u0131m amac\u0131yla tutarl\u0131 \u015fekilde de\u011ferlendirilmelidir. Klinik ara\u015ft\u0131rma yap\u0131lmamas\u0131n\u0131n gerek\u00e7esi \u00fcr\u00fcn\u00fcn risk profili, mevcut veri seviyesi ve Article 61 istisnalar\u0131 \u00fczerinden a\u00e7\u0131k\u00e7a yaz\u0131lmal\u0131d\u0131r. Klinik veri yeterlili\u011fi, risk-fayda sonucu ve pazarlama iddialar\u0131 aras\u0131nda izlenebilir ba\u011flant\u0131 kurulmal\u0131d\u0131r. Firma \u00f6zelinde \u00fcr\u00fcn s\u0131n\u0131f\u0131, kullan\u0131m amac\u0131 ve pazar \u00fclkesi de\u011fi\u015fti\u011finde sonu\u00e7 de\u011fi\u015febilece\u011fi i\u00e7in karar kay\u0131t alt\u0131na al\u0131nm\u0131\u015f bir mevzuat de\u011ferlendirmesiyle desteklenmelidir.<\/p>","protected":false},"excerpt":{"rendered":"
MDR alt\u0131nda klinik de\u011ferlendirme, sadece y\u00fcksek s\u0131n\u0131f cihazlar i\u00e7in de\u011fil t\u00fcm t\u0131bbi cihazlar i\u00e7in g\u00fcvenlik ve performans kan\u0131t\u0131n\u0131n bir par\u00e7as\u0131d\u0131r. […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","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":""},"kkqa_category":[455],"kkqa_letter":[465],"class_list":["post-13522","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-klinik-degerlendirme","kkqa_letter-a"],"_links":{"self":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13522","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question"}],"about":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/kkqa_question"}],"author":[{"embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=13522"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13522\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13522"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13522"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13522"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}