{"id":7982,"date":"2025-09-12T08:43:36","date_gmt":"2025-09-12T08:43:36","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/urun\/mdr-medical-device-regulation-genel-egitimi-katilim-sertifikali\/"},"modified":"2026-06-26T12:04:07","modified_gmt":"2026-06-26T12:04:07","slug":"mdr-medical-device-regulation-genel-egitimi-katilim-sertifikali","status":"publish","type":"product","link":"https:\/\/www.kalitekit.com.tr\/en\/product\/mdr-medical-device-regulation-genel-egitimi-katilim-sertifikali\/","title":{"rendered":"MDR (Medical Device Regulation) Genel E\u011fitimi \u2013 Kat\u0131l\u0131m Sertifikal\u0131"},"content":{"rendered":"
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KaliteKit Dan\u0131\u015fmanl\u0131k<\/div>\n

MDR 2017\/745 Genel Bilgilendirme E\u011fitimi<\/h1>\n

T\u0131bbi cihaz sekt\u00f6r\u00fcnde g\u00f6rev alan profesyoneller i\u00e7in haz\u0131rlanm\u0131\u015f, PDF e\u011fitim dok\u00fcman\u0131, \u00e7evrim i\u00e7i s\u0131nav ve do\u011frulanabilir dijital sertifika i\u00e7eren kapsaml\u0131 e\u011fitim program\u0131.<\/p>\n<\/div>\n

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30<\/div>\n
S\u0131nav Sorusu<\/div>\n<\/div>\n
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45<\/div>\n
Dakika S\u0131nav S\u00fcresi<\/div>\n<\/div>\n
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70<\/div>\n
Ba\u015far\u0131 Puan\u0131<\/div>\n<\/div>\n
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2<\/div>\n
S\u0131nav Hakk\u0131<\/div>\n<\/div>\n<\/div>\n
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E\u011fitim Hakk\u0131nda<\/h2>\n

Avrupa Birli\u011fi T\u0131bbi Cihaz Reg\u00fclasyonu MDR 2017\/745 E\u011fitimi<\/strong>; t\u0131bbi cihaz sekt\u00f6r\u00fcnde faaliyet g\u00f6steren \u00fcreticiler, kalite y\u00f6netim birimleri, teknik ekipler, mevzuat sorumlular\u0131 ve sekt\u00f6re yeni ba\u015flayan profesyoneller i\u00e7in haz\u0131rlanm\u0131\u015ft\u0131r.<\/p>\n

E\u011fitim kapsam\u0131nda MDR 2017\/745\u2019in temel yap\u0131s\u0131, ekonomik operat\u00f6rlerin y\u00fck\u00fcml\u00fcl\u00fckleri, t\u0131bbi cihazlar\u0131n s\u0131n\u0131fland\u0131r\u0131lmas\u0131, teknik dok\u00fcmantasyon, uygunluk de\u011ferlendirme s\u00fcre\u00e7leri, klinik de\u011ferlendirme, risk y\u00f6netimi, UDI sistemi, piyasaya arz sonras\u0131 g\u00f6zetim ve vigilans s\u00fcre\u00e7leri sistematik bi\u00e7imde ele al\u0131nmaktad\u0131r.<\/p>\n<\/section>\n

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E\u011fitim Nas\u0131l Ger\u00e7ekle\u015ftirilir?<\/h2>\n
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1<\/div>\n
Kat\u0131l\u0131mc\u0131 e\u011fitimi sat\u0131n ald\u0131ktan sonra KaliteKit hesab\u0131 \u00fczerinden PDF e\u011fitim dok\u00fcman\u0131na eri\u015fir.<\/strong><\/div>\n<\/div>\n
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2<\/div>\n
E\u011fitim dok\u00fcman\u0131n\u0131 kendi \u00e7al\u0131\u015fma temposuna g\u00f6re indirerek veya \u00e7evrim i\u00e7i inceleyerek tamamlar.<\/div>\n<\/div>\n
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3<\/div>\n
Haz\u0131r oldu\u011funda KaliteKit web sitesindeki 30 soruluk \u00e7evrim i\u00e7i s\u0131nava<\/strong> girer.<\/div>\n<\/div>\n
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4<\/div>\n
S\u0131nav i\u00e7in toplam 45 dakika<\/strong> s\u00fcre ve 2 s\u0131nav hakk\u0131<\/strong> bulunmaktad\u0131r.<\/div>\n<\/div>\n
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5<\/div>\n
S\u0131navdan en az 70 puan<\/strong> alan kat\u0131l\u0131mc\u0131 ba\u015far\u0131l\u0131 say\u0131l\u0131r ve ad\u0131na dijital sertifika olu\u015fturulur.<\/div>\n<\/div>\n<\/div>\n<\/section>\n
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E\u011fitimde Ele Al\u0131nan Ba\u015fl\u0131ca Konular<\/h2>\n
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\u2713 MDR 2017\/745\u2019in kapsam\u0131 ve temel kavramlar\u0131<\/div>\n
\u2713 \u0130malat\u00e7\u0131lar\u0131n genel y\u00fck\u00fcml\u00fcl\u00fckleri<\/div>\n
\u2713 Yetkili temsilci, ithalat\u00e7\u0131 ve da\u011f\u0131t\u0131c\u0131 sorumluluklar\u0131<\/div>\n
\u2713 Mevzuata uyumdan sorumlu ki\u015fi<\/div>\n
\u2713 T\u0131bbi cihaz s\u0131n\u0131fland\u0131rma kurallar\u0131<\/div>\n
\u2713 Uygunluk de\u011ferlendirme y\u00f6ntemleri<\/div>\n
\u2713 Onaylanm\u0131\u015f kurulu\u015flar\u0131n rol\u00fc<\/div>\n
\u2713 Genel g\u00fcvenlik ve performans \u015fartlar\u0131<\/div>\n
\u2713 Teknik dosya ve teknik dok\u00fcmantasyon<\/div>\n
\u2713 AB Uygunluk Beyan\u0131 ve CE i\u015fareti<\/div>\n
\u2713 Klinik de\u011ferlendirme ve klinik kan\u0131t<\/div>\n
\u2713 Risk y\u00f6netimi yakla\u015f\u0131m\u0131<\/div>\n
\u2713 Etiketleme ve kullan\u0131m k\u0131lavuzu<\/div>\n
\u2713 UDI ve Basic UDI-DI sistemi<\/div>\n
\u2713 EUDAMED ve kay\u0131t s\u00fcre\u00e7leri<\/div>\n
\u2713 Piyasaya arz sonras\u0131 g\u00f6zetim<\/div>\n
\u2713 PMCF ve sat\u0131\u015f sonras\u0131 klinik takip<\/div>\n
\u2713 Vigilans ve ciddi olay bildirimi<\/div>\n
\u2713 Geri \u00e7a\u011f\u0131rma ve saha g\u00fcvenli\u011fi faaliyetleri<\/div>\n
\u2713 MDR ge\u00e7i\u015f h\u00fck\u00fcmleri<\/div>\n<\/div>\n<\/section>\n
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Kimler Kat\u0131labilir?<\/h2>\n
    \n
  • T\u0131bbi cihaz imalat\u00e7\u0131lar\u0131<\/li>\n
  • Kalite y\u00f6netim sistemi sorumlular\u0131<\/li>\n
  • Kalite g\u00fcvence personeli<\/li>\n
  • Reg\u00fclasyon ve mevzuat uzmanlar\u0131<\/li>\n
  • \u00dcr\u00fcn geli\u015ftirme ve Ar-Ge ekipleri<\/li>\n
  • Teknik dosya haz\u0131rlayan personel<\/li>\n
  • \u00dcretim ve kalite kontrol \u00e7al\u0131\u015fanlar\u0131<\/li>\n
  • \u0130\u00e7 tetkik\u00e7iler<\/li>\n
  • \u0130thalat\u00e7\u0131 ve da\u011f\u0131t\u0131c\u0131 \u00e7al\u0131\u015fanlar\u0131<\/li>\n
  • Sekt\u00f6re yeni ba\u015flayan profesyoneller<\/li>\n<\/ul>\n<\/section>\n
    \n

    \u00c7evrim \u0130\u00e7i S\u0131nav ve Ba\u015far\u0131 Ko\u015fullar\u0131<\/h2>\n
    S\u0131nav d\u00fczeni:<\/strong> 30 soru, 45 dakika, 2 s\u0131nav hakk\u0131 ve 70\/100 ba\u015far\u0131 puan\u0131.<\/div>\n

    S\u0131nav ba\u015flat\u0131ld\u0131\u011f\u0131 anda 45 dakikal\u0131k s\u00fcre i\u015flemeye ba\u015flar. S\u00fcre sonunda s\u0131nav sistem taraf\u0131ndan otomatik olarak sonland\u0131r\u0131labilir ve verilen cevaplar de\u011ferlendirmeye al\u0131n\u0131r.<\/p>\n

    Kat\u0131l\u0131mc\u0131n\u0131n iki s\u0131nav hakk\u0131ndan herhangi birinde en az 70 puan almas\u0131 halinde ba\u015far\u0131l\u0131 say\u0131l\u0131r. Her iki s\u0131nav hakk\u0131nda da ba\u015far\u0131 puan\u0131na ula\u015f\u0131lamamas\u0131 durumunda yeni bir s\u0131nav hakk\u0131 otomatik olarak tan\u0131mlanmaz.<\/p>\n<\/section>\n

    \n

    Dijital Sertifika<\/h2>\n

    S\u0131navdan en az 70 puan alan kat\u0131l\u0131mc\u0131 ad\u0131na KaliteKit Dan\u0131\u015fmanl\u0131k taraf\u0131ndan E\u011fitim Kat\u0131l\u0131m ve Ba\u015far\u0131 Sertifikas\u0131<\/strong> d\u00fczenlenir.<\/p>\n

    \n
    \u2713 Kat\u0131l\u0131mc\u0131 ad\u0131 ve soyad\u0131<\/div>\n
    \u2713 E\u011fitim ad\u0131<\/div>\n
    \u2713 S\u0131nav puan\u0131<\/div>\n
    \u2713 D\u00fczenlenme tarihi<\/div>\n
    \u2713 Benzersiz sertifika numaras\u0131<\/div>\n
    \u2713 QR kod ve do\u011frulama ba\u011flant\u0131s\u0131<\/div>\n<\/div>\n

    Sertifikan\u0131n \u00fczerindeki QR kod okutularak veya sertifika numaras\u0131 KaliteKit web sitesindeki do\u011frulama alan\u0131na girilerek sertifika \u00e7evrim i\u00e7i do\u011frulanabilir. Dijital sertifika e\u011fitim \u00fccretine dahildir. Talep edilmesi halinde ayr\u0131ca \u00fccret kar\u015f\u0131l\u0131\u011f\u0131nda bas\u0131l\u0131 sertifika g\u00f6nderilebilir.<\/p>\n<\/section>\n

    \n

    \u26a0 Telif Haklar\u0131 ve Kullan\u0131m Ko\u015fullar\u0131<\/h2>\n

    Bu e\u011fitim kapsam\u0131nda sunulan PDF dok\u00fcmanlar\u0131, e\u011fitim metinleri, g\u00f6rseller, tablolar, \u015femalar, s\u0131nav sorular\u0131, cevap se\u00e7enekleri, sertifika tasar\u0131mlar\u0131 ve di\u011fer t\u00fcm e\u011fitim materyalleri KaliteKit Dan\u0131\u015fmanl\u0131k taraf\u0131ndan haz\u0131rlanm\u0131\u015ft\u0131r.<\/strong> \u0130\u00e7eriklerin t\u00fcm fikr\u00ee ve s\u0131nai m\u00fclkiyet haklar\u0131 KaliteKit Dan\u0131\u015fmanl\u0131k\u2019a aittir.<\/p>\n

    E\u011fitim i\u00e7erikleri yaln\u0131zca e\u011fitimi sat\u0131n alan ki\u015finin bireysel kullan\u0131m\u0131 i\u00e7in sunulmaktad\u0131r. KaliteKit Dan\u0131\u015fmanl\u0131k\u2019\u0131n \u00f6nceden verilmi\u015f yaz\u0131l\u0131 izni olmadan i\u00e7eriklerin tamam\u0131 veya herhangi bir b\u00f6l\u00fcm\u00fc:<\/p>\n

      \n
    • Kopyalanamaz veya \u00e7o\u011falt\u0131lamaz.<\/li>\n
    • Ba\u015fka ki\u015filere g\u00f6nderilemez veya payla\u015f\u0131lamaz.<\/li>\n
    • \u0130nternet, sosyal medya veya mesajla\u015fma gruplar\u0131nda yay\u0131mlanamaz.<\/li>\n
    • Ba\u015fka bir e\u011fitimde veya ticari faaliyette kullan\u0131lamaz.<\/li>\n
    • De\u011fi\u015ftirilerek yeniden yay\u0131mlanamaz, sat\u0131lamaz veya \u00fc\u00e7\u00fcnc\u00fc ki\u015filerin eri\u015fimine a\u00e7\u0131lamaz.<\/li>\n<\/ul>\n

      E\u011fitim dok\u00fcman\u0131n\u0131n indirilmesine izin verilmesi, telif haklar\u0131n\u0131n kullan\u0131c\u0131ya devredildi\u011fi anlam\u0131na gelmez.<\/p>\n<\/section>\n

      \n

      \u00d6nemli Bilgilendirme<\/h2>\n

      Bu e\u011fitim genel bilgilendirme ve mesleki geli\u015fim amac\u0131yla haz\u0131rlanm\u0131\u015ft\u0131r. Hukuki veya d\u00fczenleyici dan\u0131\u015fmanl\u0131k, resm\u00ee uygunluk de\u011ferlendirmesi, onaylanm\u0131\u015f kurulu\u015f e\u011fitimi, akredite e\u011fitim, ba\u015f denet\u00e7i yetkilendirmesi veya resm\u00ee mesleki yeterlilik belgesi niteli\u011fi ta\u015f\u0131maz.<\/p>\n

      E\u011fitim sonunda d\u00fczenlenen sertifika; kat\u0131l\u0131mc\u0131n\u0131n KaliteKit Dan\u0131\u015fmanl\u0131k taraf\u0131ndan sunulan e\u011fitim dok\u00fcman\u0131n\u0131 tamamlad\u0131\u011f\u0131n\u0131 ve 30 sorudan olu\u015fan, 45 dakika s\u00fcreli \u00e7evrim i\u00e7i s\u0131navdan en az 70 puan ald\u0131\u011f\u0131n\u0131 g\u00f6sterir. Sertifika herhangi bir kamu kurumu, standardizasyon kurulu\u015fu, onaylanm\u0131\u015f kurulu\u015f veya akreditasyon kurumu taraf\u0131ndan verilmi\u015f resm\u00ee bir yetki belgesi olarak de\u011ferlendirilemez.<\/p>\n<\/section>\n<\/div>","protected":false},"excerpt":{"rendered":"

      KaliteKit Dan\u0131\u015fmanl\u0131k MDR 2017\/745 Genel Bilgilendirme E\u011fitimi T\u0131bbi cihaz sekt\u00f6r\u00fcnde g\u00f6rev alan profesyoneller i\u00e7in haz\u0131rlanm\u0131\u015f, PDF e\u011fitim dok\u00fcman\u0131, \u00e7evrim i\u00e7i […]<\/p>\n","protected":false},"featured_media":7601,"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":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","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":""}}},"product_brand":[],"product_cat":[14],"product_tag":[],"class_list":["post-7982","product","type-product","status-publish","has-post-thumbnail","product_cat-genel","desktop-align-left","tablet-align-left","mobile-align-left","first","instock","virtual","sold-individually","taxable","purchasable","product-type-simple"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/product\/7982","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=7982"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media\/7601"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=7982"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/product_brand?post=7982"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/product_cat?post=7982"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/product_tag?post=7982"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}