PMS sistemi, \u00fcr\u00fcn piyasaya \u00e7\u0131kt\u0131ktan sonra g\u00fcvenlilik ve performans bilgisinin planl\u0131 \u015fekilde toplanmas\u0131d\u0131r. \u015eikayetler, sat\u0131\u015f hacmi, literat\u00fcr, kullan\u0131c\u0131 geri bildirimleri, servis kay\u0131tlar\u0131, vigilance verileri ve klinik deneyim bu sistemin girdileridir. Toplanan veriler yaln\u0131zca raporlanmamal\u0131; risk y\u00f6netimi, klinik de\u011ferlendirme, IFU, tasar\u0131m de\u011fi\u015fikli\u011fi ve CAPA kararlar\u0131na geri beslenmelidir. PMCF veya PSUR ihtiyac\u0131 cihaz s\u0131n\u0131f\u0131, klinik veri bo\u015flu\u011fu, risk profili ve piyasadaki deneyime g\u00f6re gerek\u00e7elendirilmelidir. Konu d\u00fc\u015f\u00fck riskli g\u00f6r\u00fcnse bile yanl\u0131\u015f s\u0131n\u0131fland\u0131rma veya yanl\u0131\u015f rol atamas\u0131 daha sonra kay\u0131t ve piyasa g\u00f6zetimi problemi olu\u015fturabilir.<\/p>","protected":false},"excerpt":{"rendered":"
PMS sistemi, \u00fcr\u00fcn piyasaya \u00e7\u0131kt\u0131ktan sonra g\u00fcvenlilik ve performans bilgisinin planl\u0131 \u015fekilde toplanmas\u0131d\u0131r. \u015eikayetler, sat\u0131\u015f hacmi, literat\u00fcr, kullan\u0131c\u0131 geri bildirimleri, […]<\/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":[504],"kkqa_letter":[480],"class_list":["post-13674","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-pms-pmcf-psur","kkqa_letter-p"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13674","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=13674"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13674\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13674"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13674"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13674"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}