\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. 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":"
\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":[465],"class_list":["post-13718","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-ekonomik-operatorler","kkqa_letter-a"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13718","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=13718"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13718\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13718"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13718"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13718"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}