{"id":44458,"date":"2022-05-30T12:01:11","date_gmt":"2022-05-30T10:01:11","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/new-eu-medical-devices-regulations-training-two-day-virtual-seminar-essential-tasks-to-complete-the-eu-mdr-implementation-and-transition-october-12-13-2022-researchandmarkets-com\/"},"modified":"2022-05-30T12:01:11","modified_gmt":"2022-05-30T10:01:11","slug":"new-eu-medical-devices-regulations-training-two-day-virtual-seminar-essential-tasks-to-complete-the-eu-mdr-implementation-and-transition-october-12-13-2022-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/new-eu-medical-devices-regulations-training-two-day-virtual-seminar-essential-tasks-to-complete-the-eu-mdr-implementation-and-transition-october-12-13-2022-researchandmarkets-com\/","title":{"rendered":"New EU Medical Devices Regulations Training: Two Day Virtual Seminar &#8211; Essential Tasks to Complete the EU MDR Implementation and Transition (October 12-13, 2022) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5595750\/the-new-eu-medical-devices-regulations-training?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=3smlqx&amp;utm_campaign=1706365+-+New+EU+Medical+Devices+Regulations+Training%3A+Two+Day+Virtual+Seminar+-+Essential+Tasks+to+Complete+the+EU+MDR+Implementation+and+Transition+(October+12-13%2C+2022)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;The New EU Medical Devices Regulations Training &#8211; Essential Tasks to Complete the EU MDR Implementation and Transition&#8221;<\/a> training has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220530005162\/en\/1470217\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220530005162\/en\/1470217\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThis 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share lessons learned so your organization can benefit from the mistakes of others.\n<\/p>\n<p>\nWe will review the latest changes to the regulations effective and in force and will draw out key developments and key dates. The looming EU MDR crisis: Protect your patients.\n<\/p>\n<p>\nRegulatory affairs executives are currently focused on organizing and managing the final steps of the transition to align corporate strategies with new requirements and processes.\n<\/p>\n<p>\nThis seminar will focus on the time remaining in the transition period and what companies can expect from notified bodies and regulators as the implementation deadline draws to a close, as well as clarifying areas of uncertainty such as implementing acts and defining sufficient clinical evidence.\n<\/p>\n<p>\nThe new EU Medical Devices Regulations (the MDR and IVDR) for medical devices and 2022 (for in vitro diagnostic medical devices). The European Commission and medical device coordination group (MDCG) are busy preparing the guidance documents and implementing legislation to ensure the Regulations can function.\n<\/p>\n<p>\nNotified bodies are also going through the designation procedure to ensure they can accept applications under the MDR and that products can be placed on the market under the new Regulations. However, there is still much to do, and progress has been slow.\n<\/p>\n<p>\n<strong>Seminar Objectives<\/strong>\n<\/p>\n<ul>\n<li>\nUnderstand the regulatory requirements EU-MDR and the impact on Post Market Surveillance\n<\/li>\n<li>\nUnderstand how to apply those requirements\n<\/li>\n<li>\nExplain the new regulatory expectations regarding Risk Management\n<\/li>\n<li>\nUnderstand the consequences of non-compliance\n<\/li>\n<\/ul>\n<p>\n<strong>Those who work for manufacturers that market and commercialize devices in Europe including:<\/strong>\n<\/p>\n<ul>\n<li>\nMedical Device Manufacturers and Professionals within Senior Management\n<\/li>\n<li>\nRegulatory Affairs Managers and Quality Managers\n<\/li>\n<li>\nR&amp; D specialists, Development\n<\/li>\n<li>\nManufacturing and Marketing Managers\n<\/li>\n<li>\nInternal and External Auditors, Importers\n<\/li>\n<li>\nDistributors and other medical device professionals in areas of Design\n<\/li>\n<li>\nRisk Management, and Post-market activities\n<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>DAY 1<\/strong>\n<\/p>\n<ul>\n<li>\nOverview of the EU-MDR, focusing specifically on key changes\n<\/li>\n<li>\nHow to plan and scope your EU-MDR transition program\n<\/li>\n<li>\nHow to conduct a thorough gap analysis specific to EU-MDR transition\n<\/li>\n<li>\nHow to scale your transition program to encompass the entire operation\n<\/li>\n<li>\nThe key steps of implementing an EU-MDR transition program\n<\/li>\n<li>\nTimeline consideration\n<\/li>\n<li>\nReview new EU-MDR Requirements impacting Post Market Surveillance:\n<\/li>\n<li>\nDiscuss Post-Market Surveillance plans and what data should be included in the Technical Documentation\n<\/li>\n<\/ul>\n<p>\n<strong>DAY 2<\/strong>\n<\/p>\n<ul>\n<li>\nDiscuss proactive and systematic approaches to collecting and assessing information\n<\/li>\n<li>\nReview suitable indicators for benefit-risk analysis\n<\/li>\n<li>\nReview how to proper investigate complaints\n<\/li>\n<li>\nDiscuss methods for trend reports\n<\/li>\n<li>\nDiscuss methods and protocols to communicate effectively with Competent Authorities (CAs), Notified Bodies, users\n<\/li>\n<li>\nPeriodic Safety Update Report (PSUR)\n<\/li>\n<li>\nDiscuss effective tools to trace and identify devices for which corrective actions are necessary\n<\/li>\n<li>\nDiscuss Post-market Clinical Follow-up (PMCF) plan\n<\/li>\n<\/ul>\n<p>\nFor more information about this training visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5595750\/the-new-eu-medical-devices-regulations-training?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=3smlqx&amp;utm_campaign=1706365+-+New+EU+Medical+Devices+Regulations+Training%3A+Two+Day+Virtual+Seminar+-+Essential+Tasks+to+Complete+the+EU+MDR+Implementation+and+Transition+(October+12-13%2C+2022)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/svul98<\/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=\"&#109;&#x61;&#105;&#x6c;t&#x6f;:&#112;&#x72;&#101;&#x73;&#115;&#x40;r&#x65;s&#101;&#x61;&#114;&#x63;h&#x61;n&#x64;&#x6d;&#97;&#x72;&#107;&#x65;t&#x73;&#46;&#99;&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#112;r&#x65;s&#x73;&#64;&#x72;&#101;&#x73;&#101;&#x61;&#114;c&#x68;a&#x6e;d&#x6d;&#97;&#x72;&#107;&#x65;&#116;&#x73;&#46;c&#x6f;m<\/a><br \/>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;The New EU Medical Devices Regulations Training &#8211; Essential Tasks to Complete the EU MDR Implementation and Transition&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share lessons learned so your organization &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/new-eu-medical-devices-regulations-training-two-day-virtual-seminar-essential-tasks-to-complete-the-eu-mdr-implementation-and-transition-october-12-13-2022-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-44458","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>New EU Medical Devices Regulations Training: Two Day Virtual Seminar - Essential Tasks to Complete the EU MDR Implementation and Transition (October 12-13, 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\/new-eu-medical-devices-regulations-training-two-day-virtual-seminar-essential-tasks-to-complete-the-eu-mdr-implementation-and-transition-october-12-13-2022-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New EU Medical Devices Regulations Training: Two Day Virtual Seminar - Essential Tasks to Complete the EU MDR Implementation and Transition (October 12-13, 2022) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;The New EU Medical Devices Regulations Training &#8211; Essential Tasks to Complete the EU MDR Implementation and Transition&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. 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