{"id":8997,"date":"2025-10-02T08:36:55","date_gmt":"2025-10-02T08:36:55","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?page_id=8997"},"modified":"2026-07-31T05:58:08","modified_gmt":"2026-07-31T05:58:08","slug":"ivdr-urun-siniflandirma-kiti","status":"publish","type":"page","link":"https:\/\/www.kalitekit.com.tr\/en\/ivdr-urun-siniflandirma-kiti\/","title":{"rendered":"IVDR \u00dcr\u00fcn S\u0131n\u0131fland\u0131rma Kiti"},"content":{"rendered":"

IVDR \u00fcr\u00fcn s\u0131n\u0131fland\u0131rma, in vitro tan\u0131 cihazlar\u0131n\u0131n IVDR 2017\/746 kapsam\u0131ndaki risk s\u0131n\u0131f\u0131n\u0131 ve uygunluk de\u011ferlendirme yolunu belirlemek i\u00e7in kritik bir ad\u0131md\u0131r. IVD cihazlar genel olarak A, B, C ve D s\u0131n\u0131flar\u0131 alt\u0131nda de\u011ferlendirilir. Cihaz\u0131n s\u0131n\u0131f\u0131; kullan\u0131m amac\u0131, hedef analit, klinik karar \u00fczerindeki etkisi, hasta riski, test sonucunun kullan\u0131laca\u011f\u0131 ba\u011flam ve kullan\u0131c\u0131 profili dikkate al\u0131narak belirlenir.<\/p>\n\n\n\n

IVDR kapsam\u0131nda do\u011fru s\u0131n\u0131fland\u0131rma yap\u0131lmadan teknik dosya, performans de\u011ferlendirme ve CE onay s\u00fcrecine ba\u015flanmas\u0131 \u00f6nemli uyumsuzluklara yol a\u00e7abilir. \u00d6zellikle yanl\u0131\u015f risk s\u0131n\u0131f\u0131 se\u00e7imi, onaylanm\u0131\u015f kurulu\u015f gereklili\u011finin hatal\u0131 de\u011ferlendirilmesine, eksik performans kan\u0131tlar\u0131na ve yetersiz teknik dok\u00fcmantasyon yap\u0131s\u0131na neden olabilir.<\/p>\n\n\n\n

Bu IVDR \u00fcr\u00fcn s\u0131n\u0131fland\u0131rma kiti, IVD cihazlar\u0131n s\u0131n\u0131fland\u0131rma yakla\u015f\u0131m\u0131n\u0131 \u00f6n de\u011ferlendirme amac\u0131yla anlamaya yard\u0131mc\u0131 olmak i\u00e7in haz\u0131rlanm\u0131\u015ft\u0131r. Ara\u00e7, cihaz\u0131n kullan\u0131m amac\u0131, test tipi, hedef hasta grubu, sonu\u00e7lar\u0131n klinik etkisi ve IVDR s\u0131n\u0131fland\u0131rma kurallar\u0131 hakk\u0131nda daha sistematik d\u00fc\u015f\u00fcn\u00fclmesini sa\u011flar.<\/p>\n\n\n\n

IVDR \u00fcr\u00fcn s\u0131n\u0131fland\u0131rma s\u00fcrecinde yaln\u0131zca cihaz ad\u0131 veya \u00fcr\u00fcn grubu dikkate al\u0131nmamal\u0131d\u0131r. Ayn\u0131 \u00fcr\u00fcn ailesindeki farkl\u0131 cihazlar, kullan\u0131m amac\u0131 veya klinik etkisi nedeniyle farkl\u0131 de\u011ferlendirme gerektirebilir. Bu nedenle s\u0131n\u0131fland\u0131rma karar\u0131 teknik dosya, performans de\u011ferlendirme plan\u0131, risk y\u00f6netimi ve etiket\/kullan\u0131m k\u0131lavuzu i\u00e7eri\u011fiyle birlikte ele al\u0131nmal\u0131d\u0131r.<\/p>\n\n\n\n

KaliteKit, IVDR \u00fcr\u00fcn s\u0131n\u0131fland\u0131rma, IVDR teknik dosya, performans de\u011ferlendirme plan\u0131, performans de\u011ferlendirme raporu, risk y\u00f6netimi ve CE onay yolu belirleme s\u00fcre\u00e7lerinde IVD cihaz firmalar\u0131na profesyonel dan\u0131\u015fmanl\u0131k deste\u011fi sunar. Bu ara\u00e7, firmalar\u0131n IVDR s\u0131n\u0131fland\u0131rma s\u00fcrecine daha kontroll\u00fc ve denetime haz\u0131r \u015fekilde haz\u0131rlanmas\u0131na yard\u0131mc\u0131 olmak amac\u0131yla geli\u015ftirilmi\u015ftir. IVDR \u00fcr\u00fcn s\u0131n\u0131fland\u0131rma sonucuna g\u00f6re IVDR onay yolu<\/a>, IVDR teknik dosya<\/a> ve performans de\u011ferlendirme plan\u0131<\/a> birlikte haz\u0131rlanmal\u0131d\u0131r.<\/p>\n\n\n

\ud83d\udd12<\/span>

Bu ara\u00e7 korumal\u0131d\u0131r<\/h3>

Bu arac\u0131 kullanmak i\u00e7in \u00fccretsiz hesab\u0131n\u0131za giri\u015f yap\u0131n.<\/p>\u00dccretsiz giri\u015f yap \/ hesap olu\u015ftur<\/a><\/div><\/div>","protected":false},"excerpt":{"rendered":"

IVDR \u00fcr\u00fcn s\u0131n\u0131fland\u0131rma, in vitro tan\u0131 cihazlar\u0131n\u0131n IVDR 2017\/746 kapsam\u0131ndaki risk s\u0131n\u0131f\u0131n\u0131 ve uygunluk de\u011ferlendirme yolunu belirlemek i\u00e7in kritik bir […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","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":""},"class_list":["post-8997","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/pages\/8997","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/page"}],"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=8997"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/pages\/8997\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=8997"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}