{"id":4921,"date":"2020-06-22T11:12:33","date_gmt":"2020-06-22T09:12:33","guid":{"rendered":"https:\/\/www.idisantiago.es\/akm-webinar-nuevo-marco-regulatorio-para-dispositivos-medicos-y-diagnostico-in-vitro-registrese-25-26-junio-2020\/"},"modified":"2020-06-30T13:10:01","modified_gmt":"2020-06-30T11:10:01","slug":"akm-webinar-nuevo-marco-regulatorio-para-dispositivos-medicos-y-diagnostico-in-vitro-registrese","status":"publish","type":"post","link":"https:\/\/www.idisantiago.es\/en\/akm-webinar-nuevo-marco-regulatorio-para-dispositivos-medicos-y-diagnostico-in-vitro-registrese\/","title":{"rendered":"AKM Webinar &#8220;New Regulatory Framework for Medical Devices and In-Vitro Diagnostic&#8221;. July 16, 2020"},"content":{"rendered":"\n<p>The <a href=\"https:\/\/atlantic-ketmed.eu\/\">ATLANTIC KET MED<\/a> project continues to carry out training activities in webinar format. <\/p>\n\n\n\n<p>The main theme of the next webinar will be the <strong>New Regulatory Framework for Medical Devices and In Vitro Diagnostics<\/strong>.<\/p>\n\n\n\n<p><strong>July 16th. 11:00h CEST (Madrid hour). 10:00h (UK hour)<\/strong><\/p>\n\n\n\n<p><strong><span style=\"font-family: Arial, sans-serif;\"><span>Ne<\/span><\/span><span style=\"font-family: Arial, sans-serif;\"><span>w<\/span><\/span><span style=\"font-family: Arial, sans-serif;\"><span>&nbsp;Regulatory Framework for Medical Devices and In-Vitro Diagnostic<\/span><\/span><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>What does CE mark mean?<\/li><li>What is a Medical Device and In-Vitro diagnostic?<\/li><li>Classification system: concepts and rules<\/li><li>Milestones to CE Mark<\/li><li><\/li><\/ul>\n\n\n\n<p><strong>Regulatory Concepts to CE Mark under MDR or IVDR<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>CE mark: Importance of the Technical documents.<\/li><li>General safety and performance requirements (GSPR).<\/li><li>Technical standards and guidelines.<\/li><li>Product risks analysis<\/li><li>Performance evaluation under MDR \/ IVDR\u200b<\/li><\/ul>\n\n\n\n<p><a href=\"https:\/\/www.asphalion.com\/\">Asphalion<\/a>, an international scientific and regulatory&nbsp;affairs\u200b consultancy &nbsp;will provide the training.<\/p>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-background\" href=\"\/download\/4886\/\" style=\"background-color:#333366\">Program<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-default\"><a class=\"wp-block-button__link has-background\" href=\"https:\/\/atlantic-ketmed.eu\/webinar3\/\" style=\"background-color:#333366\">Sign up here<\/a><\/div>\n\n\n\n<p>Once registered you will receive a personal link by email that you will use to access the live Webinar.<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ATLANTIC KET MED project continues to carry out training activities in webinar format. The main theme of the next webinar will be the New Regulatory Framework for Medical Devices [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":7331,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[216],"tags":[143,220,221,222],"class_list":["post-4921","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-theses","tag-atlantic-ket-med","tag-webinars","tag-atlantic-ket-med-en","tag-webinars-en"],"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.idisantiago.es\/en\/wp-json\/wp\/v2\/posts\/4921","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.idisantiago.es\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.idisantiago.es\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.idisantiago.es\/en\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.idisantiago.es\/en\/wp-json\/wp\/v2\/comments?post=4921"}],"version-history":[{"count":6,"href":"https:\/\/www.idisantiago.es\/en\/wp-json\/wp\/v2\/posts\/4921\/revisions"}],"predecessor-version":[{"id":4987,"href":"https:\/\/www.idisantiago.es\/en\/wp-json\/wp\/v2\/posts\/4921\/revisions\/4987"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.idisantiago.es\/en\/wp-json\/wp\/v2\/media\/7331"}],"wp:attachment":[{"href":"https:\/\/www.idisantiago.es\/en\/wp-json\/wp\/v2\/media?parent=4921"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.idisantiago.es\/en\/wp-json\/wp\/v2\/categories?post=4921"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.idisantiago.es\/en\/wp-json\/wp\/v2\/tags?post=4921"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}