Legacy cihazlarda ge\u00e7i\u015f ko\u015fullar\u0131 s\u00fcrerken MDR\u2019nin PMS, piyasa g\u00f6zetimi, vijilans ve ekonomik operat\u00f6r kay\u0131t y\u00fck\u00fcml\u00fcl\u00fckleri uygulan\u0131r; ayr\u0131ca \u00f6nemli de\u011fi\u015fiklik yap\u0131lmamas\u0131 ve ge\u00e7erli sertifika\/QMS ko\u015fullar\u0131 korunmal\u0131d\u0131r. Denetim a\u00e7\u0131s\u0131ndan \u00f6nemli olan yaln\u0131z sonu\u00e7 de\u011fil, karar\u0131n kan\u0131tlanabilir gerek\u00e7esidir. Kalite ve reg\u00fclasyon ekibinin birlikte kontrol etmesi gereken alanlar cihaz\u0131n intended purpose\u2019u, s\u0131n\u0131fland\u0131rma kural\u0131, ge\u00e7i\u015f stat\u00fcs\u00fc, uygunluk de\u011ferlendirme yolu ve teknik dosya kan\u0131tlar\u0131n\u0131n tutarl\u0131l\u0131\u011f\u0131 olmal\u0131d\u0131r. Ge\u00e7i\u015f hakk\u0131; ge\u00e7erli eski direktif sertifikas\u0131, \u00f6nemli de\u011fi\u015fiklik yap\u0131lmamas\u0131, uygun QMS\/NB s\u00f6zle\u015fmesi ve MDR sonras\u0131 y\u00fck\u00fcml\u00fcl\u00fcklerin s\u00fcrd\u00fcr\u00fclmesine ba\u011fl\u0131d\u0131r. Denetim dosyas\u0131nda s\u0131n\u0131fland\u0131rma gerek\u00e7esi, MDR Ek II-III teknik dosyas\u0131, GSPR matrisi, risk y\u00f6netim dosyas\u0131, CER, PMS plan\u0131, etiket\/IFU ve uygunluk beyan\u0131 birlikte g\u00f6sterilmelidir. Bu yakla\u015f\u0131m MDR 2017\/745 uygunlu\u011fu, t\u0131bbi cihaz teknik dosyas\u0131 ve CE belgelendirme s\u00fcreci ba\u015fl\u0131klar\u0131n\u0131n ayn\u0131 \u00fcr\u00fcn verisine dayanmas\u0131n\u0131 sa\u011flar. B\u00f6ylece konu, yaln\u0131z mevzuat yorumu olarak de\u011fil uygulanm\u0131\u015f bir kalite sistemi kontrol\u00fc olarak g\u00f6sterilebilir.<\/p>","protected":false},"excerpt":{"rendered":"
Legacy cihazlarda ge\u00e7i\u015f ko\u015fullar\u0131 s\u00fcrerken MDR\u2019nin PMS, piyasa g\u00f6zetimi, vijilans ve ekonomik operat\u00f6r kay\u0131t y\u00fck\u00fcml\u00fcl\u00fckleri uygulan\u0131r; ayr\u0131ca \u00f6nemli de\u011fi\u015fiklik yap\u0131lmamas\u0131 […]<\/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":[447],"kkqa_letter":[476],"class_list":["post-13638","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-mdr","kkqa_letter-l"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13638","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/kkqa_question"}],"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=13638"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13638\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13638"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13638"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13638"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}