{"id":4433,"date":"2026-06-04T13:29:58","date_gmt":"2026-06-04T10:29:58","guid":{"rendered":"https:\/\/demo.erayonetim.com\/?page_id=4433"},"modified":"2026-06-04T13:44:56","modified_gmt":"2026-06-04T10:44:56","slug":"useful-resources-terms-glossary","status":"publish","type":"page","link":"https:\/\/erayonetim.com\/en\/faydali-kaynaklar-terimler-sozluk\/","title":{"rendered":"Useful Resources & Glossary of Terms"},"content":{"rendered":"

\n

\n

\n

\n

\n \r\n\t
\r\n\t\t
\r\n\t\t\t

\ud83d\udd17 Useful Resources & Glossary<\/h4>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n
\n <\/div><\/div>
\n <\/div>\n

\n

\n \r\n\t
\r\n\t\t
\r\n\t\t\t
\n

\ud83c\udf0d Important Regulations and Standards<\/h3>\n\n\n\n\n\n\n\n\n\n\n
Source<\/th>\nExplanation<\/th>\nLink<\/th>\n<\/tr>\n
MDCG<\/td>\nEU medical device regulations guidance and information documents<\/td>\nMDCG Official Page<\/a><\/td>\n<\/tr>\n
2017\/745 MDR<\/td>\nEuropean Union Medical Device Regulation<\/td>\nEUR-Lex MDR Text<\/a><\/td>\n<\/tr>\n
2017\/746 IVDR<\/td>\nEuropean Union In Vitro Diagnostic Devices Regulation<\/td>\nEUR-Lex IVDR Text<\/a><\/td>\n<\/tr>\n
ISO Standards<\/td>\nInternational standards (ISO 13485, ISO 14971, ISO 14155, etc.)<\/td>\nISO Official Website<\/a><\/td>\n<\/tr>\n
ASTM Standards<\/td>\nAmerican Society for Testing and Materials standards<\/td>\nASTM Official Website<\/a><\/td>\n<\/tr>\n
FDA<\/td>\nU.S. Food and Drug Administration, medical device regulations<\/td>\nFDA Medical Devices<\/a><\/td>\n<\/tr>\n
SFDA<\/td>\nSaudi Arabia Food and Drug Administration<\/td>\nSFDA Official Website<\/a><\/td>\n<\/tr>\n
EUDAMED<\/td>\nEU Medical Device Database (registration and traceability)<\/td>\nEUDAMED Portal<\/a><\/td>\n<\/tr>\n<\/table>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n
\n <\/div><\/div>
\n <\/div>\n

\n

\n \r\n\t
\r\n\t\t
\r\n\t\t\t
\n

\ud83d\udcda Glossary of Terms<\/h3>\n
\n

MDR:<\/strong> Medical Device Regulation, EU medical device regulation (2017\/745)<\/p>\n

IVDR:<\/strong> In Vitro Diagnostic Regulation, EU in vitro diagnostic devices regulation (2017\/746)<\/p>\n

PMCF:<\/strong> Post-market clinical follow-up is the clinical monitoring process that takes place after a product is released to the market.<\/p>\n

CRO:<\/strong> Clinical Research Organization<\/p>\n

ANCHOR:<\/strong> Corrective and Preventive Action<\/p>\n

NB:<\/strong> Notified Body, authorized organization<\/p>\n

ISO 13485:<\/strong> Quality management system standard for medical devices.<\/p>\n

ISO 14971:<\/strong> Risk management standard for medical devices.<\/p>\n

ISO 14155:<\/strong> Medical device clinical trial standard<\/p>\n

GSPR:<\/strong> General Safety and Performance Requirements (MDR Annex I)<\/p>\n

MOC:<\/strong> Management of Change, the change management process.<\/p>\n

EUDAMED:<\/strong> EU medical devices database and registration system.<\/p>\n

SFDA:<\/strong> Saudi Arabia Food and Drug Administration<\/p>\n

FDA:<\/strong> U.S. Food and Drug Administration<\/p>\n

Legacy Product:<\/strong> Products that are currently available and regulated in the existing market.<\/p>\n<\/div>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n
\n <\/div><\/div>
\n <\/div>\n


\n

\n \r\n\t
\r\n\t\t
\r\n\t\t\t
\n

\ud83d\udce5 Additional Resources<\/h3>\n
    \n
  • \u2022 MDR and IVDR Adoption Guidelines<\/li>\n
  • \u2022 ISO Standards Summary and Purchase Links<\/li>\n
  • \u2022 Clinical Trial Protocol Templates<\/li>\n
  • \u2022 Regulatory Updates and News<\/li>\n<\/ul>\n
    \n

    \ud83d\udccc Note:<\/p>\n

    This page will be updated regularly to ensure compliance with current legal regulations and standards. Furthermore, its scope can be expanded based on suggestions and requests from users.<\/p>\n<\/div>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n
    \n <\/div><\/div>
    \n <\/div>
    \n <\/div><\/div>
    \n <\/div><\/div><\/div>
    \n<\/section>\n<\/div>","protected":false},"excerpt":{"rendered":"\ud83d\udd17 Faydal\u0131 Kaynaklar & Terimler S\u00f6zl\u00fc\u011f\u00fc \ud83c\udf0d \u00d6nemli Reg\u00fclasyonlar ve Standartlar Kaynak A\u00e7\u0131klama Link MDCG AB t\u0131bbi cihaz reg\u00fclasyonlar\u0131 konusunda rehber ve bilgilendirme dok\u00fcmanlar\u0131 MDCG Resmi Sayfas\u0131 2017\/745 MDR Avrupa Birli\u011fi T\u0131bbi Cihaz Reg\u00fclasyonu (Medical Device Regulation) EUR-Lex MDR Metni 2017\/746 IVDR Avrupa Birli\u011fi In Vitro Tan\u0131 Cihazlar\u0131 Reg\u00fclasyonu EUR-Lex IVDR Metni ISO Standartlar\u0131 Uluslararas\u0131 [...]","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"rs_blank_template":"","rs_page_bg_color":"","slide_template_v7":"","footnotes":""},"class_list":["post-4433","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/erayonetim.com\/en\/wp-json\/wp\/v2\/pages\/4433","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/erayonetim.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/erayonetim.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/erayonetim.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/erayonetim.com\/en\/wp-json\/wp\/v2\/comments?post=4433"}],"version-history":[{"count":8,"href":"https:\/\/erayonetim.com\/en\/wp-json\/wp\/v2\/pages\/4433\/revisions"}],"predecessor-version":[{"id":4442,"href":"https:\/\/erayonetim.com\/en\/wp-json\/wp\/v2\/pages\/4433\/revisions\/4442"}],"wp:attachment":[{"href":"https:\/\/erayonetim.com\/en\/wp-json\/wp\/v2\/media?parent=4433"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}