\u00d6nce yaz\u0131l\u0131m\u0131n t\u0131bbi ama\u00e7 ta\u015f\u0131y\u0131p ta\u015f\u0131mad\u0131\u011f\u0131, tan\u0131\/tedavi karar\u0131n\u0131 etkileyip etkilemedi\u011fi ve kullan\u0131c\u0131ya sundu\u011fu \u00e7\u0131kt\u0131n\u0131n klinik karar \u00fczerindeki a\u011f\u0131rl\u0131\u011f\u0131 belirlenmelidir. AI veya SaMD bile\u015fenlerinde model s\u00fcr\u00fcm\u00fc, e\u011fitim-verifikasyon veri setleri, validasyon y\u00f6ntemi, siber g\u00fcvenlik \u00f6nlemleri, insan g\u00f6zetimi ve hata senaryolar\u0131 teknik dosyada izlenebilir olmal\u0131d\u0131r. De\u011fi\u015fiklikler performans iddias\u0131n\u0131 veya risk profilini etkiliyorsa sadece yaz\u0131l\u0131m versiyon notu yeterli olmaz; risk y\u00f6netimi, klinik\/performance de\u011ferlendirme ve gerekirse onaylanm\u0131\u015f kurulu\u015f ileti\u015fimi g\u00fcncellenmelidir. Etiket ve IFU taraf\u0131nda verilen her bilgi \u00fcr\u00fcn ad\u0131, kullan\u0131m amac\u0131, uyar\u0131lar, ekonomik operat\u00f6r bilgileri ve kay\u0131t sistemlerindeki verilerle tutarl\u0131 olmal\u0131d\u0131r. Firma \u00f6zelinde \u00fcr\u00fcn s\u0131n\u0131f\u0131, kullan\u0131m amac\u0131 ve pazar \u00fclkesi de\u011fi\u015fti\u011finde sonu\u00e7 de\u011fi\u015febilece\u011fi i\u00e7in karar kay\u0131t alt\u0131na al\u0131nm\u0131\u015f bir mevzuat de\u011ferlendirmesiyle desteklenmelidir.<\/p>","protected":false},"excerpt":{"rendered":"
\u00d6nce yaz\u0131l\u0131m\u0131n t\u0131bbi ama\u00e7 ta\u015f\u0131y\u0131p ta\u015f\u0131mad\u0131\u011f\u0131, tan\u0131\/tedavi karar\u0131n\u0131 etkileyip etkilemedi\u011fi ve kullan\u0131c\u0131ya sundu\u011fu \u00e7\u0131kt\u0131n\u0131n klinik karar \u00fczerindeki a\u011f\u0131rl\u0131\u011f\u0131 belirlenmelidir. AI […]<\/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-13375","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\/13375","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=13375"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13375\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13375"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13375"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13375"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}