{"id":9733,"date":"2019-06-12T09:30:22","date_gmt":"2019-06-12T07:30:22","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=9733"},"modified":"2019-06-12T09:30:22","modified_gmt":"2019-06-12T07:30:22","slug":"what-is-the-post-market-surveillance-system","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2019\/06\/12\/what-is-the-post-market-surveillance-system\/","title":{"rendered":"What is the &#8220;post-market surveillance system&#8221;?"},"content":{"rendered":"\n<p>The <strong>post-market surveillance system<\/strong>\n(PMS) serves to \u201c<em>collect, record and actively and systematically analyze the\nrelevant data on the quality, performance and safety of a device during the\nentire validity period, to draw the necessary conclusions and to determine,\nimplement and monitor any preventive and corrective actions<\/em>&#8221; (Ref.\nArt. 83 of the MDR).<\/p>\n\n\n\n<p>The need for such a system arises immediately\nafter the device is marketed. The PMS system serves not only to meet regulatory\nrequirements, but also to improve risk management and improve the quality of a\nmedical device. The PMS system also serves to appropriately identify problems\nin the design and\/or the use of the device and to accurately characterize the\nbehavior of the device under normal conditions of use and the obtained clinical\nresults.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/06\/post-market-surveillance-system-1024x536.jpg\" alt=\"\" class=\"wp-image-9734\"\/><figcaption><em>Post-market surveillance system<\/em><\/figcaption><\/figure>\n\n\n\n<p>Vigilance is also part of the PMS system. <em>Post-market\nclinical follow-up<\/em> (PMCF, for medical devices) and <em>post-market\nperformance follow-up<\/em> (PMPF, for IVDs) are &#8220;living&#8221; parts of the\nPMS system and fundamental elements of the QMS, continuos processes that are\npart of the clinical\/performance evaluation aimed at bridging the gap between\nthe evidence gathered during the pre-market phase and the PMS data collected with\nthe device already in use.<\/p>\n\n\n\n<p style=\"background-color:#0099aa;text-align:center\" class=\"has-text-color has-background has-very-light-gray-color\">Questions? Request more info from our specialists&nbsp;<br><a rel=\"noreferrer noopener\" href=\"http:\/\/www.thema-med.com\/en\/contact-us-2\/\" target=\"_blank\">CONTACT US<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The post-market surveillance system (PMS) serves to \u201ccollect, record and actively and systematically analyze the relevant data on the quality, performance  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[892,1554],"tags":[],"class_list":["post-9733","post","type-post","status-publish","format-standard","hentry","category-faq-en","category-mdr-impact-ce-mdd-certificates-period-of-grace"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>What is the &quot;post-market surveillance system&quot;? 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