IVDR de\u011ferlendirmesinde intended purpose, test edilen analit, numune tipi, kullan\u0131c\u0131 profili, sonu\u00e7lar\u0131n klinik karar \u00fczerindeki etkisi ve s\u0131n\u0131fland\u0131rma kural\u0131 birlikte incelenmelidir. RUO, self-test, companion diagnostic veya near-patient test gibi ifadeler \u00fcr\u00fcn\u00fcn y\u00fck\u00fcml\u00fcl\u00fcklerini ciddi \u015fekilde etkileyebilir. Performans de\u011ferlendirme dosyas\u0131nda bilimsel ge\u00e7erlilik, analitik performans ve klinik performans ayr\u0131 ayr\u0131 g\u00f6sterilmelidir. Legacy cihazlar i\u00e7in ge\u00e7i\u015f h\u00fck\u00fcmleri olsa bile PMS, vigilance ve kalite sistemi y\u00fck\u00fcml\u00fcl\u00fckleri devam eder; bu nedenle dosya yaln\u0131zca eski IVDD mant\u0131\u011f\u0131yla b\u0131rak\u0131lmamal\u0131d\u0131r. 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":"
IVDR de\u011ferlendirmesinde intended purpose, test edilen analit, numune tipi, kullan\u0131c\u0131 profili, sonu\u00e7lar\u0131n klinik karar \u00fczerindeki etkisi ve s\u0131n\u0131fland\u0131rma kural\u0131 birlikte […]<\/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":[448],"kkqa_letter":[473],"class_list":["post-13669","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-ivdr","kkqa_letter-i"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13669","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=13669"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13669\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13669"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13669"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13669"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}