{"id":528,"date":"2023-04-25T11:39:58","date_gmt":"2023-04-25T09:39:58","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=528"},"modified":"2023-04-25T11:39:58","modified_gmt":"2023-04-25T09:39:58","slug":"rl15-preparation-of-technical-documentation-in-accordance-with-regulation-eu-2017-746","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/regulatory-quality-trainings\/rl15-preparation-of-technical-documentation-in-accordance-with-regulation-eu-2017-746\/","title":{"rendered":"RL15 – Preparation of Technical Documentation in accordance with Regulation (EU) 2017\/746"},"content":{"rendered":"\n
\n

REF. RL15 – 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

To place In Vitro<\/em> Diagnostic Medical Devices on the market in Europe, the requirements of Regulation (EU) 2017\/746 must be met.<\/p>\n\n\n\n

The Technical Documentation the manufacturer must draw up and present must be clear, organized and unambiguous, in a form that can be easily read, and include, in particular, the items listed in Annexes II and III of the MDR.<\/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

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

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
  • Identify requirements to draw up the Technical Documentation according to Regulation (EU) 2017\/746<\/li>\n\n\n\n
  • Know how to draw up the Technical Documentation and ensure it is up to date<\/li>\n\n\n\n
  • Integrate the Technical Documentation requirements into the design process<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
    <\/div>\n\n\n\n
    \n

    TARGET TRAINEES<\/h2>\n\n\n\n

    Manufacturers of In Vitro<\/em> Diagnostic Medical Devices, and more particularly: <\/p>\n\n\n\n

      \n
    • Regulatory Affairs<\/li>\n\n\n\n
    • R&D<\/li>\n\n\n\n
    • Any individual involved in the preparation or review of the technical documentation<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
      <\/div>\n\n\n\n
      \n

      PREREQUISITES<\/h2>\n\n\n\n

      Familiarity with Regulation (EU) 2017\/746 is a plus.<\/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
      • Case studies<\/li>\n\n\n\n
      • Experience sharing<\/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. Regulatory review<\/li>\n\n\n\n
        2. Technical documentation objectives <\/li>\n\n\n\n
        3. Technical documentation structure and format\n
            \n
          • The basic elements and ties to the design and production file<\/li>\n\n\n\n
          • Content of the different sections<\/li>\n\n\n\n
          • File coherence: key points<\/li>\n<\/ul>\n<\/li>\n\n\n\n
          • The roles that contribute to the compilation of the technical documentation <\/li>\n\n\n\n
          • Tie to the ISO 13485:2016 quality management system: post-market surveillance – Change control<\/li>\n\n\n\n
          • Notified body sampling of technical documentation reviews<\/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. RL15 – INTRA \/ INTER EUROPEAN REGULATIONS COURSE DESCRIPTION To place In Vitro Diagnostic Medical Devices on the market in Europe, the requirements of Regulation (EU) 2017\/746 must be met. The Technical Documentation the manufacturer must draw up and present must be clear, organized and unambiguous, in a form that can be easily read, […]<\/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\/528"}],"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=528"}],"version-history":[{"count":1,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/528\/revisions"}],"predecessor-version":[{"id":529,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/528\/revisions\/529"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=528"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=528"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=528"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}