{"id":46669,"date":"2022-07-28T11:01:54","date_gmt":"2022-07-28T09:01:54","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/virtual-training-course-an-introduction-to-the-medical-device-regulation-november-8-10-2022-researchandmarkets-com\/"},"modified":"2022-07-28T11:01:54","modified_gmt":"2022-07-28T09:01:54","slug":"virtual-training-course-an-introduction-to-the-medical-device-regulation-november-8-10-2022-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/virtual-training-course-an-introduction-to-the-medical-device-regulation-november-8-10-2022-researchandmarkets-com\/","title":{"rendered":"Virtual Training Course: An Introduction to the Medical Device Regulation (November 8-10, 2022) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5578689\/an-introduction-to-the-medical-device-regulation?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=d3fl52&amp;utm_campaign=1731028+-+Virtual+Training+Course%3A+An+Introduction+to+the+Medical+Device+Regulation++(November+8-10%2C+2022)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;An Introduction to the Medical Device Regulation Training Course&#8221;<\/a> conference has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220728005490\/en\/1527740\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220728005490\/en\/1527740\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThis seminar provides an invaluable overview of the European Medical Device Regulation (MDR). The interactive programme will explain the new legislation and which products are covered, the involvement of Notified Bodies and how to choose one and will outline a manufacturer&#8217;s responsibilities. It will also cover the documentation necessary to apply for the CE mark.\n<\/p>\n<p>\nThis is an excellent introduction from leading experts in the field and delegates should expect three days of intensive training.\n<\/p>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<p>\nPast delegates include those working in regulatory affairs, pharmacovigilance, quality assurance and technical support. This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.\n<\/p>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>What is a medical device?<\/strong>\n<\/p>\n<ul>\n<li>\nDefinition\n<\/li>\n<li>\nExamples\n<\/li>\n<\/ul>\n<p>\n<strong>Europe and the MDR &#8211; overview of the regulations applicable for bringing a medical device to market<\/strong>\n<\/p>\n<p>\n<strong>Economic operators and other parties<\/strong>\n<\/p>\n<ul>\n<li>\nWho are they?\n<\/li>\n<li>\nHow do they interrelate?\n<\/li>\n<li>\nWhat are their responsibilities?\n<\/li>\n<\/ul>\n<p>\n<strong>Classification of devices<\/strong>\n<\/p>\n<ul>\n<li>\nWhat are the classes and how do we classify devices?\n<\/li>\n<\/ul>\n<p>\n<strong>Conformity assessment procedures<\/strong>\n<\/p>\n<ul>\n<li>\nThe routes to CE marking\n<\/li>\n<li>\nWhat is required for each class of device?\n<\/li>\n<\/ul>\n<p>\n<strong>Workshop 1: Classification<\/strong>\n<\/p>\n<p>\n<strong>Manufacturers&#8217; responsibilities<\/strong>\n<\/p>\n<ul>\n<li>\nTechnical file and design dossier requirements\n<\/li>\n<\/ul>\n<p>\n<strong>Quality systems<\/strong>\n<\/p>\n<ul>\n<li>\nEN ISO 13485: 2012 and 2016\n<\/li>\n<li>\nThe requirements for a quality system\n<\/li>\n<\/ul>\n<p>\n<strong>Labelling of devices<\/strong>\n<\/p>\n<ul>\n<li>\nUse of language and symbols\n<\/li>\n<li>\nInstructions for use\n<\/li>\n<\/ul>\n<p>\n<strong>Workshop 2: Labelling<\/strong>\n<\/p>\n<p>\n<strong>Clinical evaluations<\/strong>\n<\/p>\n<ul>\n<li>\nEuropean regulatory environment\n<\/li>\n<li>\nWhen are clinical investigations necessary?\n<\/li>\n<li>\nWhat is required by the competent authority, Ethics Committee and Notified Body?\n<\/li>\n<\/ul>\n<p>\n<strong>Workshop 3: CE marking<\/strong>\n<\/p>\n<p>\n<strong>Medical device vigilance<\/strong>\n<\/p>\n<ul>\n<li>\nAdverse event reporting\n<\/li>\n<li>\nReporting requirements\n<\/li>\n<li>\nPost-market surveillance (PMS)\n<\/li>\n<\/ul>\n<p>\n<strong>Workshop 4: Vigilance<\/strong>\n<\/p>\n<p>\n<strong>Drug\/device combinations<\/strong>\n<\/p>\n<ul>\n<li>\nDrug or device?\n<\/li>\n<li>\nExamples of classification\n<\/li>\n<\/ul>\n<p>\n<strong>Devices incorporating material of animal origin<\/strong>\n<\/p>\n<ul>\n<li>\nAnimal-derived materials legislation\n<\/li>\n<li>\nDirective 2003\/32\/EC\n<\/li>\n<\/ul>\n<p>\n<strong>The revision to the regulations for medical devices<\/strong>\n<\/p>\n<p>\nFor more information about this conference visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5578689\/an-introduction-to-the-medical-device-regulation?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=d3fl52&amp;utm_campaign=1731028+-+Virtual+Training+Course%3A+An+Introduction+to+the+Medical+Device+Regulation++(November+8-10%2C+2022)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/ewyo<\/a>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nResearchAndMarkets.com<br \/>\n<br \/>Laura Wood, Senior Press Manager<br \/>\n<br \/><a target=\"_blank\" href=\"m&#97;&#105;&#x6c;&#x74;o:&#112;&#114;&#x65;&#x73;s&#64;&#114;&#101;&#x73;&#x65;ar&#99;&#x68;&#x61;&#x6e;d&#109;&#97;&#x72;&#x6b;&#x65;t&#115;&#46;&#x63;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x70;&#x72;&#x65;&#x73;&#x73;&#x40;&#x72;&#x65;&#x73;&#x65;&#x61;&#x72;&#x63;&#x68;&#x61;&#x6e;&#x64;&#x6d;&#x61;&#x72;&#x6b;&#x65;&#x74;&#x73;&#x2e;&#x63;&#x6f;&#x6d;<\/a><\/p>\n<p>For E.S.T Office Hours Call 1-917-300-0470<br \/>\n<br \/>For U.S.\/CAN Toll Free Call 1-800-526-8630<br \/>\n<br \/>For GMT Office Hours Call +353-1-416-8900\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;An Introduction to the Medical Device Regulation Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. This seminar provides an invaluable overview of the European Medical Device Regulation (MDR). The interactive programme will explain the new legislation and which products are covered, the involvement of Notified Bodies and how to choose one and &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/virtual-training-course-an-introduction-to-the-medical-device-regulation-november-8-10-2022-researchandmarkets-com\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-46669","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Virtual Training Course: An Introduction to the Medical Device Regulation (November 8-10, 2022) - ResearchAndMarkets.com - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/virtual-training-course-an-introduction-to-the-medical-device-regulation-november-8-10-2022-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Virtual Training Course: An Introduction to the Medical Device Regulation (November 8-10, 2022) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;An Introduction to the Medical Device Regulation Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. 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