{"id":3968,"date":"2023-05-16T09:32:16","date_gmt":"2023-05-16T07:32:16","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/uncategorized\/medical-device-clinical-evaluation\/"},"modified":"2026-02-04T09:45:21","modified_gmt":"2026-02-04T08:45:21","slug":"medical-device-clinical-evaluation","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/medical-device\/medical-device-clinical-evaluation\/","title":{"rendered":"Medical device clinical evaluation"},"content":{"rendered":"<p>With the applicability of Regulation (EU) 2017\/745, there is a need to review the approach to the preparation of the clinical evaluation, which until now has been carried out mainly based on the guidance provided by the MEDDEV guidelines. The need to submit new documents (such as the Clinical Evaluation Plan and PMCF Plan) and the need to interface with PMS activities certainly make this task more complex than in the past. Although the topic is covered extensively in the new Regulations, to the requirements of which are added the indications of the various documents issued by the MDCG, there is a lack of a unified document that, by summarizing the requirements of the regulations, provides valuable guidance for the preparation of clinical evaluation. The training course \u201cMedical device clinical evaluation\u201d aims to offer a unified view of the various relevant documents, and also to propose a possible practical approach to the preparation of the clinical evaluation.<\/p>\n<p><strong>Would you like to participate, but you&#8217;re not available on this date?<\/strong><\/p>\n<p>The course will be provided again:<\/p>\n<ul>\n<li>November 12th 2024<\/li>\n<li>May 14th 2025<\/li>\n<\/ul>\n<p>(*) Contact us via email or phone to enroll.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>With the applicability of Regulation (EU) 2017\/745, there is a need to review the approach to the preparation of the clinical evaluation, which until now has been carried out mainly based on the guidance provided by the MEDDEV guidelines. The need to submit new documents (such as the Clinical Evaluation Plan and PMCF Plan) and the need to interface with PMS activities certainly make this task more complex than in the past.<\/p>\n","protected":false},"featured_media":3517,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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\u2013 17:00 COURSE SESSION\r\n\r\nThe Regulatory Context\r\n\r\nClinical evaluation according to Regulation (EU) 2017\/745\r\n<ul>\r\n \t<li>The founding principles<\/li>\r\n \t<li>The legal basis<\/li>\r\n<\/ul>\r\nThe most relevant novelties\r\n<ul>\r\n \t<li>The clinical evaluation plan<\/li>\r\n \t<li>The post-marketing clinical follow-up (PMCF)<\/li>\r\n \t<li>The relationship with post-marketing surveillance (PMS) and risk assessment<\/li>\r\n \t<li>Other relevant aspects<\/li>\r\n<\/ul>\r\nThe clinical evaluation document: a practical approach\r\n<ul>\r\n \t<li>The different phases of the clinical evaluation<\/li>\r\n<\/ul>","corso_target":"Regulatory Affairs, Quality Assurance, management personnel, research and development managers, production managers, process managers, managers\/coordinators, complaint management and corrective and preventive actions, supervisory managers, marketing\/sales managers.","corso_competenze":[{"corso_competenze_item":"Better understand the requirements of the new regulations with reference to clinical evaluation"},{"corso_competenze_item":"Clarify how clinical evaluation will fit into the context of other planned activities for medical devices"},{"corso_competenze_item":"Verify the content of the various documents issued by the MDCG"},{"corso_competenze_item":"Deepen some aspects related to the clinical evaluation of \"legacy devices\""},{"corso_competenze_item":"Better understand the various steps in the clinical evaluation process"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/3968","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media\/3517"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=3968"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=3968"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=3968"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=3968"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}