
{"id":13123,"date":"2026-05-19T07:04:18","date_gmt":"2026-05-19T07:04:18","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/sadece-yazilimdan-olusan-bir-ivd-cihazi-ivdr-kapsaminda-nasil-siniflandirilir\/"},"modified":"2026-05-19T07:04:18","modified_gmt":"2026-05-19T07:04:18","slug":"sadece-yazilimdan-olusan-bir-ivd-cihazi-ivdr-kapsaminda-nasil-siniflandirilir","status":"publish","type":"kkqa_question","link":"https:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/sadece-yazilimdan-olusan-bir-ivd-cihazi-ivdr-kapsaminda-nasil-siniflandirilir\/","title":{"rendered":"Sadece yaz\u0131l\u0131mdan olu\u015fan bir IVD cihaz\u0131 IVDR kapsam\u0131nda nas\u0131l s\u0131n\u0131fland\u0131r\u0131l\u0131r?"},"content":{"rendered":"<p>Bu konuda ilk kontrol, yaz\u0131l\u0131m\u0131n kendi ba\u015f\u0131na t\u0131bbi ama\u00e7 ta\u015f\u0131y\u0131p ta\u015f\u0131mad\u0131\u011f\u0131 ve klinik karar \u00fczerinde do\u011frudan etkisi olup olmad\u0131\u011f\u0131d\u0131r. IVD yaz\u0131l\u0131mlar\u0131 ama\u00e7lanan kullan\u0131m, verdi\u011fi klinik karar etkisi ve IVDR s\u0131n\u0131fland\u0131rma kurallar\u0131 \u00fczerinden de\u011ferlendirilir. \u00dcretici; yaz\u0131l\u0131m ya\u015fam d\u00f6ng\u00fcs\u00fc, risk kontrol \u00f6nlemleri, do\u011frulama\/ge\u00e7erli k\u0131lma kay\u0131tlar\u0131, siber g\u00fcvenlik ve klinik performans kan\u0131tlar\u0131n\u0131 teknik dosyada birbirine ba\u011flamal\u0131d\u0131r. Sadece &#8216;ara\u015ft\u0131rma&#8217;, &#8216;AI&#8217; veya &#8216;mobil uygulama&#8217; ifadesi kullan\u0131lmas\u0131 MDR\/IVDR kapsam\u0131n\u0131 otomatik ortadan kald\u0131rmaz.<\/p>","protected":false},"excerpt":{"rendered":"<p>Bu konuda ilk kontrol, yaz\u0131l\u0131m\u0131n kendi ba\u015f\u0131na t\u0131bbi ama\u00e7 ta\u015f\u0131y\u0131p ta\u015f\u0131mad\u0131\u011f\u0131 ve klinik karar \u00fczerinde do\u011frudan etkisi olup olmad\u0131\u011f\u0131d\u0131r. IVD [&hellip;]<\/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":[506],"kkqa_letter":[465],"class_list":["post-13123","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-yazilim-samd","kkqa_letter-a"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13123","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=13123"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13123\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13123"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13123"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13123"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}