{"id":534,"date":"2023-04-25T11:46:54","date_gmt":"2023-04-25T09:46:54","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=534"},"modified":"2023-04-25T11:46:55","modified_gmt":"2023-04-25T09:46:55","slug":"rl20-post-market-surveillance-of-medical-devices","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/regulatory-quality-trainings\/rl20-post-market-surveillance-of-medical-devices\/","title":{"rendered":"RL20 – Post-Market Surveillance of Medical Devices"},"content":{"rendered":"\n
\n

REF. RL20 – INTRA \/ INTER<\/p>\n\n\n\n

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

<\/div>\n\n\n\n
\n

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

The demonstration of a 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\/745.\u00a0<\/p>\n<\/div><\/div>\n\n\n\n

<\/div>\n\n\n\n
\n\t
\n\t\t

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

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

\n\t\t\n\t\t

IN-PERSON<\/h3>\n\t<\/div>\n
\n\t\t\n\t\t

VIRTUAL CLASSROOM<\/h3>\n\t<\/div>\n<\/div>\n\n\n\n
\n

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 \u201cpost-market surveillance\u201d and post-market clinical follow-up<\/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
    • MD 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\/745<\/li>\n\n\n\n
              • Practical guidelines<\/li>\n<\/ul>\n<\/li>\n\n\n\n
              • Documents to be drafted\n
                  \n
                • PMS and PMCF 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
                • 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 >= 75%).<\/em><\/p>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

                    REF. RL20 – INTRA \/ INTER EUROPEAN REGULATIONS COURSE DESCRIPTION The demonstration of a 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 […]<\/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\/534"}],"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=534"}],"version-history":[{"count":1,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/534\/revisions"}],"predecessor-version":[{"id":535,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/534\/revisions\/535"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=534"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=534"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=534"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}