{"id":8709,"date":"2024-09-17T09:26:34","date_gmt":"2024-09-17T07:26:34","guid":{"rendered":"https:\/\/www.entecerma.it\/mdr-technical-documentation-training-for-medical-device-manufacturers\/"},"modified":"2024-09-17T09:31:08","modified_gmt":"2024-09-17T07:31:08","slug":"mdr-technical-documentation-training-for-medical-device-manufacturers","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/mdr-technical-documentation-training-for-medical-device-manufacturers\/","title":{"rendered":"MDR Technical Documentation Training for Medical Device Manufacturers"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong><em>On Wednesday 6 November 2024, Team-NB is organizing an online training course for medical device manufacturers who want to deepen their understanding of the technical documentation requirements under the MDR regulation<\/em><\/strong>.<\/h2>\n\n<p><strong>ECM<\/strong> invites medical device manufacturers to join the <em>\u201c<strong>MDR Technical Documentation Training for Manufacturers<\/strong>\u201d<\/em> to be held <strong>online on 6 November 2024<\/strong>, where we will participate as speakers. The event is intended for manufacturers and aims to strengthen collaboration between Notified Bodies and companies, addressing key topics of <strong>Regulation (EU) 2017\/745<\/strong> and providing practical guidance to optimize the preparation of technical documentation.<\/p>\n\n<div style=\"height:24px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-86998e3e61825bf0fb64071553b23910\" style=\"color:#085f9b\"><strong>A COURSE LED BY INDUSTRY EXPERTS<\/strong><\/h3>\n\n<p>The course, organized by <a href=\"https:\/\/www.team-nb.org\/\" target=\"_blank\" rel=\"noopener\"><strong><em>Team-NB<\/em><\/strong><\/a> with the involvement of professionals from 9 Notified Bodies, including <a href=\"https:\/\/www.entecerma.it\/en\/activities\/certifications\/product-and-service\/medical-devices-regulation-eu-2017-745\/\" target=\"_blank\" rel=\"noopener\">ECM<\/a>, provides a comprehensive overview of the <strong>MDR guidelines and<\/strong> <strong>requirements concerning technical documentation<\/strong>. Participants will also have the opportunity to engage directly with leading experts and receive clarifications on common issues.<\/p>\n\n<div style=\"height:24px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-6e8f8f660312a295c5f8295c77968357\" style=\"color:#085f9b\"><strong>BENEFITS FOR MANUFACTURERS AND NOTIFIED BODIES<\/strong><\/h3>\n\n<p>By adopting the best practices shared during the course, manufacturers can submit clearer and more complete technical documentation, thereby reducing the risk of non-conformities and optimizing the evaluation process by Notified Bodies. An informed and effective approach ensures efficient management of approval timelines, offering mutual advantages in terms of both time and resources.<\/p>\n\n<div style=\"height:24px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-b8770fd5cb391979cd4af4f529e7c28c\" style=\"color:#085f9b\"><strong>HOW TO PARTICIPATE<\/strong><\/h3>\n\n<p>The program includes four sessions dedicated to the structure and requirements of MDR technical documentation, focusing on the <strong>Technical File (TF) <\/strong>construction and management of <strong>General Safety and Performance Requirements (GSPR)<\/strong>, <strong>post-market surveillance (PMS)<\/strong>, and <strong>clinical data<\/strong>. Each lesson will be followed by a <strong>Q&amp;A<\/strong> session.<\/p>\n\n<p><strong>Date and time<\/strong>: Wednesday, November 6th, 2024 &#8211; 9:00-17:00 CET, online<\/p>\n\n<p><strong>Participants<\/strong>: limited to 50 organisations, with priority for SMEs registration until October 4th.<\/p>\n\n<p><strong>Download the flyer <a href=\"https:\/\/www.team-nb.org\/wp-content\/uploads\/2024\/07\/Leaflet-MDR-TD-Manufacturers-Training-20241106.pdf\" target=\"_blank\" rel=\"noopener\">here<\/a><\/strong> with all the information on how to attend.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On Wednesday 6 November 2024, Team-NB is organizing an online training course for medical device&#8230;<\/p>\n","protected":false},"author":2,"featured_media":8707,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[13,2],"tags":[551,282,128,1450,404,123,185,496,1451,553],"class_list":["post-8709","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-events","category-news","tag-corso-di-formazione-en","tag-dispositivi-medici-en","tag-mdr-2017-745-en","tag-mdr-technical-documentation-training-en","tag-medical-device-regulation-en","tag-medical-devices-en","tag-organismo-notificato-en","tag-team-nb-en","tag-technical-documentation-en","tag-training-mdr-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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