{"id":9068,"date":"2019-03-12T12:01:44","date_gmt":"2019-03-12T11:01:44","guid":{"rendered":"http:\/\/www.thema-med.com\/infografica-il-processo-di-sorveglianza-post-market\/"},"modified":"2019-03-12T12:01:44","modified_gmt":"2019-03-12T11:01:44","slug":"infographic-the-post-market-surveillance-process","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2019\/03\/12\/infographic-the-post-market-surveillance-process\/","title":{"rendered":"Infographic &#8211; the Post Market Surveillance process"},"content":{"rendered":"\n<p>Starting May 26th, 2021 (the MDR (EU) 2017\/745 application date), medical device manufacturers will have to apply the MDR requirements for post-market surveillance (PMS), vigilance, registration of operators economic and devices.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/03\/Infographic-Post-market-surveillance-process-1024x768.jpg\" alt=\"\" class=\"wp-image-9140\"\/><figcaption><em>Download the infographic: the Post Market Surveillance process<\/em><\/figcaption><\/figure>\n\n\n\n<p>The current infographic provides manufacturers an overview of a proactive and systematic <strong>post-market surveillance <\/strong>process, in line with the requirements of ISO 13485:2016 regarding the quality management system for medical devices and EN ISO 14971:2012 for production and post-production activities.<\/p>\n\n\n\n<p>The <strong>post-market surveillance <\/strong>includes all those activities that the manufacturer must prepare to implement an adequate system to actively and systematically collect, record and analyze the relevant information on the quality, performance and safety of the medical device during the entire life cycle of the device itself, in order to implement preventive and corrective actions.<\/p>\n\n\n\n<p style=\"color:#0099a8\" class=\"has-text-color\"> <strong>Fill in the form and receive the Infographic directly in your Inbox!<\/strong><br><\/p>\n\n\n\n\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f10221-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"10221\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/en\/wp-json\/wp\/v2\/posts\/9068#wpcf7-f10221-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Contact form\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"10221\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.1\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f10221-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_wpcf7cf_hidden_group_fields\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_hidden_groups\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_visible_groups\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_repeaters\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_steps\" value=\"{}\" \/><input type=\"hidden\" name=\"_wpcf7cf_options\" value=\"{&quot;form_id&quot;:10221,&quot;conditions&quot;:[],&quot;settings&quot;:{&quot;animation&quot;:&quot;yes&quot;,&quot;animation_intime&quot;:200,&quot;animation_outtime&quot;:200,&quot;conditions_ui&quot;:&quot;normal&quot;,&quot;notice_dismissed&quot;:false,&quot;notice_dismissed_update-cf7-6.1.1&quot;:true}}\" \/><input type=\"hidden\" name=\"_wpcf7dtx_version\" value=\"5.0.3\" \/><input type=\"hidden\" name=\"_wpcf7_recaptcha_response\" value=\"\" \/>\n<\/fieldset>\n<table>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Name and Surname\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"nome\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"nome\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Company\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"azienda\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"azienda\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Role\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"ruolo\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"ruolo\"><option value=\"\">&#8212;Please choose an option&#8212;<\/option><option value=\"Purchasing\">Purchasing<\/option><option value=\"Sales\">Sales<\/option><option value=\"Marketing\">Marketing<\/option><option value=\"Administration\">Administration<\/option><option value=\"QA\/RA\">QA\/RA<\/option><option value=\"Management\">Management<\/option><option value=\"R &amp; D\">R &amp; D<\/option><option value=\"Other\">Other<\/option><\/select><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Email\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"your-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"your-email\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td colspan=\"2\">\n\t\t\t<table>\n\t\t\t\t<tr>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"acceptance-729\"><span class=\"wpcf7-form-control 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Lgs. 196\/2003 adapted to the GDPR 679\/16 EU by the D. Lgs. 101\/2018, I agree to receive the CONTENT referred to in question and receive the periodic NEWSLETTER INFORMATION Thema S.r.l<br \/>\n<a href=\"https:\/\/www.thema-med.com\/en\/newsletter-information\/\">Information concerning the processing of personal data<\/a>\n\t\t\t\t\t\t<\/p>\n\t\t\t\t\t<\/td>\n\t\t\t\t<\/tr>\n\t\t\t<\/table>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>&nbsp;\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"Download the Whitepaper\" \/>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n<\/table><div class=\"fusion-alert alert custom alert-custom fusion-alert-center wpcf7-response-output fusion-alert-capitalize awb-alert-native-link-color\" style=\"--awb-border-top-left-radius:0px;--awb-border-top-right-radius:0px;--awb-border-bottom-left-radius:0px;--awb-border-bottom-right-radius:0px;\" role=\"alert\"><div class=\"fusion-alert-content-wrapper\"><span class=\"fusion-alert-content\"><\/span><\/div><\/div>\n<\/form>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"<p>Starting May 26th, 2021 (the MDR (EU) 2017\/745 application date), medical device manufacturers will have to apply the MDR requirements for  [&#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":[679],"tags":[],"class_list":["post-9068","post","type-post","status-publish","format-standard","hentry","category-blog-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Infographic - the Post Market Surveillance process - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/en\/2019\/03\/12\/infographic-the-post-market-surveillance-process\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Infographic - the Post Market Surveillance process - Thema Med\" \/>\n<meta property=\"og:description\" content=\"Starting May 26th, 2021 (the MDR (EU) 2017\/745 application date), medical device manufacturers will have to apply the MDR requirements for [...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/en\/2019\/03\/12\/infographic-the-post-market-surveillance-process\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema Med\" \/>\n<meta property=\"article:published_time\" content=\"2019-03-12T11:01:44+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/03\/Infographic-Post-market-surveillance-process-1024x768.jpg\" \/>\n<meta name=\"author\" content=\"redazione\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"redazione\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2019\/03\/12\/infographic-the-post-market-surveillance-process\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2019\/03\/12\/infographic-the-post-market-surveillance-process\/\"},\"author\":{\"name\":\"redazione\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\"},\"headline\":\"Infographic &#8211; 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