{"id":788,"date":"2019-11-02T00:38:04","date_gmt":"2019-11-02T00:38:04","guid":{"rendered":"https:\/\/www.iso-saudi.net\/blog\/?p=788"},"modified":"2019-11-02T00:38:04","modified_gmt":"2019-11-02T00:38:04","slug":"iso-13485-sfda-requirements-certification-riyadh-jeddah","status":"publish","type":"post","link":"https:\/\/www.iso-saudi.net\/blog\/iso-13485-sfda-requirements-certification-riyadh-jeddah\/","title":{"rendered":"ISO 13485 SFDA Requirements Certification Riyadh, Jeddah"},"content":{"rendered":"<p><strong>ISO 13485 SFDA Requirements Certification in Riyadh, Jeddah<\/strong><\/p>\n<p>Few of the key features and requirements of the SFDA Saudi Food and Drug administration Riyadh and Jeddah for Medical device manufacturers, medical device distributors and medical device service providers<\/p>\n<ul>\n<li>Verify MDR procedures comply with regulatory requirements<\/li>\n<li>verify medical device company maintains MDR event files that comply with regulatory requirements<\/li>\n<li>confirm medical device company appropriate MDR information is identified, reviewed, reported, documented, and filed<\/li>\n<li>ensure medical device company is effective in identifying MDR reportable events<\/li>\n<li>ensure medical device company has established procedures for receiving, reviewing, and evaluating complaints<\/li>\n<li>verify medical device company maintains complaint files and that they are reasonably accessible<\/li>\n<li>confirm medical device company that complaints are evaluated to determine if an event should be a MDR<\/li>\n<li>ensure complaint investigations include the device name, date of complaint, device identification number, contact information of complainant, details of complaint, date and results of investigation<\/li>\n<\/ul>\n<p>For free download of the ISO 13485 Audit checklist.pdf, ISO 13485 SFDA requirements.pdf, ISO 13485 SFDA Certification, ISO 13485 Consultancy requirements in Riyadh, Jeddah, Dammam, Jubail drop an email to info@iso-saudi.net<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ISO 13485 SFDA Requirements Certification in Riyadh, Jeddah Few of the key features and requirements of the SFDA Saudi Food [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","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 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