EUDAMED, yaln\u0131zca veri giri\u015f ekran\u0131 de\u011fil; akt\u00f6r, cihaz, UDI, sertifika ve piyasa g\u00f6zetimi bilgilerinin birbirine ba\u011fland\u0131\u011f\u0131 merkezi bir yap\u0131d\u0131r. Bu nedenle kay\u0131t \u00f6ncesi \u00fcretici SRN, authorised representative bilgisi, Basic UDI-DI, UDI-DI, EMDN ve cihaz s\u0131n\u0131f\u0131 kontrol edilmelidir. EUDAMED veri seti \u00fcr\u00fcn etiketi, uygunluk beyan\u0131, teknik dosya ve kalite kay\u0131tlar\u0131yla tutarl\u0131 olmal\u0131d\u0131r. Toplu kay\u0131t yap\u0131lacaksa Excel \u015fablonu, zorunlu alanlar, kod listeleri ve paket seviyeleri \u00f6nceden do\u011frulanmal\u0131d\u0131r; aksi halde hata d\u00fczeltme s\u00fcreci kay\u0131t zaman\u0131n\u0131 uzat\u0131r. Denetimde g\u00fc\u00e7l\u00fc bir cevap verebilmek i\u00e7in karar\u0131n dayand\u0131\u011f\u0131 prosed\u00fcr, kay\u0131t ve revizyon ge\u00e7mi\u015fi birlikte g\u00f6sterilmelidir.<\/p>","protected":false},"excerpt":{"rendered":"
EUDAMED, yaln\u0131zca veri giri\u015f ekran\u0131 de\u011fil; akt\u00f6r, cihaz, UDI, sertifika ve piyasa g\u00f6zetimi bilgilerinin birbirine ba\u011fland\u0131\u011f\u0131 merkezi bir yap\u0131d\u0131r. Bu […]<\/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":[450],"kkqa_letter":[469],"class_list":["post-13694","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-eudamed","kkqa_letter-e"],"_links":{"self":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13694","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=13694"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13694\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13694"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13694"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13694"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}