{"id":450,"date":"2023-04-24T18:10:26","date_gmt":"2023-04-24T16:10:26","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=450"},"modified":"2023-04-24T18:18:34","modified_gmt":"2023-04-24T16:18:34","slug":"cl09-post-market-clinical-follow-up-of-a-medical-device","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/clinical-trainings\/cl09-post-market-clinical-follow-up-of-a-medical-device\/","title":{"rendered":"CL09 – Post-Market Clinical Follow-Up of a Medical Device"},"content":{"rendered":"\n
\n

REF. CL09 – INTRA \/ INTER<\/p>\n\n\n\n

CLINICAL<\/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 a Medical Device\u2019s compliance with the General Safety and Performance Requirements requires the implementation of Post-Market Clinical Follow-Up (PMCF) to collect, record and analyze relevant clinical 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\/745.<\/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\/745 in terms of post-market surveillance and post-market clinical follow-up<\/li>\n\n\n\n
  • Become familiar with the different options regarding post-market clinical follow-up activities<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
    <\/div>\n\n\n\n
    \n

    TARGET TRAINEES<\/h2>\n\n\n\n
      \n
    • Medical Device manufacturers<\/li>\n\n\n\n
    • Medical Device 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

      No prior knowledge required<\/p>\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
      • Discussions based on the regulation and guidelines<\/li>\n\n\n\n
      • Distribution of the texts presented<\/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 clinical follow-up: context and definitions\n
            \n
          • Terms and definitions<\/li>\n\n\n\n
          • Process inherent in post-market surveillance<\/li>\n\n\n\n
          • Goals<\/li>\n<\/ul>\n<\/li>\n\n\n\n
          • Identification of regulatory requirements\n
              \n
            • Regulation (EU) 2017\/745<\/li>\n\n\n\n
            • Practical guidelines<\/li>\n\n\n\n
            • Documents to be prepared<\/li>\n<\/ul>\n<\/li>\n\n\n\n
            • Nature of PMCF activities<\/li>\n\n\n\n
            • Documents to be prepared\n
                \n
              • PMCF plan<\/li>\n\n\n\n
              • PMCF report<\/li>\n<\/ul>\n<\/li>\n\n\n\n
              • Post-market clinical data\n
                  \n
                • What data?<\/li>\n\n\n\n
                • How to analyze\/use it?<\/li>\n\n\n\n
                • Implementation of the different documents and related documents <\/li>\n\n\n\n
                • Practical examples<\/li>\n<\/ul>\n<\/li>\n\n\n\n
                • Summary\/Q&A<\/li>\n\n\n\n
                • Course 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 >= 80%).<\/em><\/p>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

                    REF. CL09 – INTRA \/ INTER CLINICAL COURSE DESCRIPTION The demonstration of a Medical Device\u2019s compliance with the General Safety and Performance Requirements requires the implementation of Post-Market Clinical Follow-Up (PMCF) to collect, record and analyze relevant clinical data on the quality, performance and safety of a device throughout its lifecycle. This system must be […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[12],"tags":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/450"}],"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=450"}],"version-history":[{"count":2,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/450\/revisions"}],"predecessor-version":[{"id":455,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/450\/revisions\/455"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=450"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=450"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=450"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}