\u00d6nce firman\u0131n yasal \u00fcretici, yetkili temsilci, ithalat\u00e7\u0131, distrib\u00fct\u00f6r veya procedure pack assembler rol\u00fcnde olup olmad\u0131\u011f\u0131 netle\u015ftirilmelidir. MDR ve IVDR\u2019de her ekonomik operat\u00f6r i\u00e7in farkl\u0131 kontrol, izlenebilirlik, uygunsuzluk bildirimi ve i\u015f birli\u011fi y\u00fck\u00fcml\u00fcl\u00fckleri vard\u0131r. S\u00f6zle\u015fmelerde teknik dosyaya eri\u015fim, \u015fikayet aktar\u0131m\u0131, vigilance bildirimi, depolama ko\u015fullar\u0131, etiket de\u011fi\u015fikli\u011fi, kay\u0131t saklama ve yetkili otorite taleplerine cevap s\u00fcresi a\u00e7\u0131k yaz\u0131lmal\u0131d\u0131r. Denetimde yaln\u0131zca s\u00f6zle\u015fme de\u011fil, bu s\u00f6zle\u015fmenin i\u015fletildi\u011fini g\u00f6steren kay\u0131tlar beklenir. Pratikte ilk yap\u0131lmas\u0131 gereken, ba\u015fl\u0131\u011f\u0131n yaln\u0131zca mevzuat maddesi olarak de\u011fil \u00fcr\u00fcn dosyas\u0131nda hangi kan\u0131tla desteklendi\u011fini kontrol etmektir.<\/p>","protected":false},"excerpt":{"rendered":"
\u00d6nce firman\u0131n yasal \u00fcretici, yetkili temsilci, ithalat\u00e7\u0131, distrib\u00fct\u00f6r veya procedure pack assembler rol\u00fcnde olup olmad\u0131\u011f\u0131 netle\u015ftirilmelidir. MDR ve IVDR\u2019de her […]<\/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":[505],"kkqa_letter":[477],"class_list":["post-13704","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-ekonomik-operatorler","kkqa_letter-m"],"_links":{"self":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13704","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=13704"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13704\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13704"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13704"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13704"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}