
{"id":13128,"date":"2026-05-19T07:04:18","date_gmt":"2026-05-19T07:04:18","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/klinik-arastirma-amacli-yazilim-ce-isareti-olmadan-kullanilabilir-mi\/"},"modified":"2026-05-19T07:04:18","modified_gmt":"2026-05-19T07:04:18","slug":"klinik-arastirma-amacli-yazilim-ce-isareti-olmadan-kullanilabilir-mi","status":"publish","type":"kkqa_question","link":"https:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/klinik-arastirma-amacli-yazilim-ce-isareti-olmadan-kullanilabilir-mi\/","title":{"rendered":"Klinik ara\u015ft\u0131rma ama\u00e7l\u0131 yaz\u0131l\u0131m CE i\u015fareti olmadan kullan\u0131labilir mi?"},"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. CE i\u015fareti gereklili\u011fi yaz\u0131l\u0131m\u0131n piyasaya arz edilip edilmedi\u011fi, ara\u015ft\u0131rma ama\u00e7l\u0131 kullan\u0131m\u0131 ve klinik karar etkisine g\u00f6re 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. CE [&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-13128","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\/13128","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=13128"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13128\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13128"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13128"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}