\u00d6nce yaz\u0131l\u0131m\u0131n t\u0131bbi ama\u00e7 ta\u015f\u0131y\u0131p ta\u015f\u0131mad\u0131\u011f\u0131 belirlenmelidir. Yaz\u0131l\u0131m tan\u0131, tedavi, izleme, karar deste\u011fi veya klinik bilgi \u00fcretimi amac\u0131yla kullan\u0131l\u0131yorsa MDR kapsam\u0131nda t\u0131bbi cihaz yaz\u0131l\u0131m\u0131 olarak de\u011ferlendirilebilir. Sadece veri saklama, ileti\u015fim veya idari i\u015f ak\u0131\u015f\u0131 sunan yaz\u0131l\u0131mlar \u00e7o\u011fu durumda farkl\u0131 de\u011ferlendirilir. Risk s\u0131n\u0131f\u0131 belirlenirken \u00e7\u0131kt\u0131n\u0131n klinik karara etkisi, hatal\u0131 sonucun hastaya verebilece\u011fi zarar, kullan\u0131c\u0131 profili, alarm\/\u00f6neri fonksiyonu ve yaz\u0131l\u0131m de\u011fi\u015fikliklerinin kontrol\u00fc incelenmelidir. AI veya makine \u00f6\u011frenmesi varsa e\u011fitim verisi, validasyon verisi, performans izleme ve siber g\u00fcvenlik de teknik dosyada a\u00e7\u0131k\u00e7a g\u00f6sterilmelidir. 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":"
Bu soru, yaz\u0131l\u0131m\u0131n kullan\u0131m amac\u0131, klinik karara etkisi, risk s\u0131n\u0131f\u0131 ve de\u011fi\u015fiklik kontrol\u00fc birlikte de\u011ferlendirilerek cevaplanmal\u0131d\u0131r.<\/p>","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-13749","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-yazilim-samd","kkqa_letter-a"],"_links":{"self":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13749","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=13749"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13749\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13749"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13749"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13749"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}