{"id":4237,"date":"2026-06-02T13:49:27","date_gmt":"2026-06-02T10:49:27","guid":{"rendered":"https:\/\/demo.erayonetim.com\/?post_type=faq&#038;p=4237"},"modified":"2026-06-02T13:49:43","modified_gmt":"2026-06-02T10:49:43","slug":"iso-14971-standard-risk-management-file-requirement","status":"publish","type":"faq","link":"https:\/\/demo.erayonetim.com\/en\/sss\/iso-14971-standart-risk-yonetimi-dosyasi-zorunlulugu\/","title":{"rendered":"Is it mandatory to prepare a Risk Management File in accordance with the ISO 14971 Standard?"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><div class=\"vc_row wpb_row row top-row wpb_custom_034b39d9bc6c6b310d69e39f0ccf274f\"><div class=\"vc_column_container col-md-12\"><div class=\"wpb_wrapper vc_column-inner\">\r\n\t<div class=\"wpb_text_column wpb_content_element wpb_custom_7c91d232724f73626cc933bd95b25ff0\" >\r\n\t\t<div class=\"wpb_wrapper\">\r\n\t\t\t<p>Yes, implementing a risk management process in accordance with the ISO 14971 standard is mandatory for all medical devices. All risks that the product may pose, from design to the end of its life cycle, must be analyzed and documented.<\/p>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>\n<\/div>","protected":false},"template":"","faq_cat":[],"class_list":["post-4237","faq","type-faq","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/faq\/4237","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/faq"}],"about":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/types\/faq"}],"wp:attachment":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/media?parent=4237"}],"wp:term":[{"taxonomy":"faq_cat","embeddable":true,"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/faq_cat?post=4237"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}