{"id":537,"date":"2023-04-25T11:49:58","date_gmt":"2023-04-25T09:49:58","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=537"},"modified":"2023-04-25T11:49:58","modified_gmt":"2023-04-25T09:49:58","slug":"rl21-post-market-surveillance-of-in-vitro-diagnostic-medical-devices","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/regulatory-quality-trainings\/rl21-post-market-surveillance-of-in-vitro-diagnostic-medical-devices\/","title":{"rendered":"RL21 – Post-Market Surveillance of In Vitro Diagnostic Medical Devices"},"content":{"rendered":"\n
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REF. RL21 – INTRA \/ INTER<\/p>\n\n\n\n

EUROPEAN REGULATIONS<\/p>\n<\/div><\/div>\n\n\n\n

<\/div>\n\n\n\n
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COURSE DESCRIPTION<\/h2>\n\n\n\n

The demonstration of an In Vitro Diagnostic Medical Device\u2019s compliance with essential requirements requires the implementation of a post-market surveillance system to collect, record and analyze relevant data on the quality, performance and safety of a device throughout its lifecycle. This system must be documented and implemented in accordance with the requirements of Regulation (EU) 2017\/746.<\/p>\n<\/div><\/div>\n\n\n\n

<\/div>\n\n\n\n
\n\t
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DURATION<\/h3>\n\t\t

1 day \/ 7 hours<\/p>\n\t<\/div>\n\t

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IN-PERSON<\/h3>\n\t<\/div>\n
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VIRTUAL CLASSROOM<\/h3>\n\t<\/div>\n<\/div>\n\n\n\n
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OBJECTIVES<\/h2>\n\n\n\n
    \n
  • Become familiar with the terms and vocabulary<\/li>\n\n\n\n
  • Understand the requirements of Regulation (EU) 2017\/746 in terms of \u201cpost-market surveillance\u201d and post-market performance follow-up (PMPF)<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
    <\/div>\n\n\n\n
    \n

    TARGET TRAINEES<\/h2>\n\n\n\n
      \n
    • Manufacturers of In Vitro Diagnostic Medical Devices<\/li>\n\n\n\n
    • IVDMD development or market operators<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
      <\/div>\n\n\n\n
      \n

      PREREQUISITES<\/h2>\n\n\n\n
        \n
      • No prior knowledge required<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
        <\/div>\n\n\n\n
        \n

        TRAINING RESOURCES<\/h2>\n\n\n\n
          \n
        • PowerPoint presentation handed out at the end of training<\/li>\n\n\n\n
        • Experience sharing based on the regulation and related guidelines<\/li>\n\n\n\n
        • Quizzes<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
          <\/div>\n\n\n\n
          \n

          COURSE CONTENT<\/h2>\n\n\n\n

          Participants welcomed and presented\/Course objectives\/Presentation of the course content<\/strong><\/p>\n\n\n\n

            \n
          1. Post-market surveillance: context and definitions\n
              \n
            • Terms and definitions<\/li>\n\n\n\n
            • Objectives<\/li>\n<\/ul>\n<\/li>\n\n\n\n
            • Identification of regulatory requirements\n
                \n
              • Regulation (EU) 2017\/746<\/li>\n\n\n\n
              • Practical guidelines<\/li>\n<\/ul>\n<\/li>\n\n\n\n
              • Documents to be drafted\n
                  \n
                • PMS and PMPF plans<\/li>\n\n\n\n
                • Post-market surveillance report<\/li>\n\n\n\n
                • Periodic safety update report (PSUR)<\/li>\n\n\n\n
                • Ties between the documents<\/li>\n<\/ul>\n<\/li>\n\n\n\n
                • Post-market surveillance data <\/li>\n\n\n\n
                • What data?<\/li>\n\n\n\n
                • How to analyze\/use it?<\/li>\n\n\n\n
                • Drawing up the different documents<\/li>\n\n\n\n
                • Practical examples<\/li>\n\n\n\n
                • Summary\/Q&A<\/li>\n\n\n\n
                • Training evaluation and conclusion<\/li>\n<\/ol>\n<\/div><\/div>\n\n\n\n
                  <\/div>\n\n\n\n
                  \n

                  EVALUATION METHODS<\/h2>\n\n\n\n
                    \n
                  • Course evaluation quiz<\/li>\n\n\n\n
                  • Satisfaction survey<\/li>\n\n\n\n
                  • Attendance certificate<\/li>\n<\/ul>\n\n\n\n

                    This training is assessed based on an evaluation of each individual\u2019s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 75%).<\/em><\/p>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

                    REF. RL21 – INTRA \/ INTER EUROPEAN REGULATIONS COURSE DESCRIPTION The demonstration of an In Vitro Diagnostic Medical Device\u2019s compliance with essential requirements requires the implementation of a post-market surveillance system to collect, record and analyze relevant data on the quality, performance and safety of a device throughout its lifecycle. This system must be documented […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[19,13],"tags":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/537"}],"collection":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/comments?post=537"}],"version-history":[{"count":1,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/537\/revisions"}],"predecessor-version":[{"id":538,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/537\/revisions\/538"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=537"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=537"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=537"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}