{"id":540,"date":"2023-04-25T11:52:42","date_gmt":"2023-04-25T09:52:42","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=540"},"modified":"2023-04-25T11:52:42","modified_gmt":"2023-04-25T09:52:42","slug":"rl22-regulation-eu-2017-745-compliance-with-the-general-safety-and-performance-requirements","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/regulatory-quality-trainings\/rl22-regulation-eu-2017-745-compliance-with-the-general-safety-and-performance-requirements\/","title":{"rendered":"RL22 – Regulation (EU) 2017\/745: Compliance with the General Safety and Performance Requirements"},"content":{"rendered":"\n
\n

REF. RL22 – 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 Medical Devices on the market in Europe, the requirements of Regulation (EU) 2017\/745 must be met.<\/p>\n\n\n\n

The manufacturer must design and manufacture its devices so as to ensure that, under normal conditions of use, they are suited for their intended use, safe and effective, and do not endanger the clinical condition or safety of patients or the safety or health of users.<\/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
\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
  • Understand and apply the general safety and performance requirements<\/li>\n\n\n\n
  • Demonstrate GSPR compliance<\/li>\n\n\n\n
  • Take GSPR into account during 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

    Medical Device manufacturers, and more particularly: <\/p>\n\n\n\n

      \n
    • Regulatory Affairs<\/li>\n\n\n\n
    • R&D<\/li>\n\n\n\n
    • All individuals involved in the device\u2019s design process<\/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\/745 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 framework<\/li>\n\n\n\n
        2. General safety and performance requirements (GSPR)\n
            \n
          • General information<\/li>\n\n\n\n
          • Tie to design and development <\/li>\n\n\n\n
          • Tie to risk management  <\/li>\n\n\n\n
          • Tie to the technical documentation<\/li>\n\n\n\n
          • Evidence to prove\/demonstrate compliance<\/li>\n<\/ul>\n<\/li>\n\n\n\n
          • GSPR review and responses\n
              \n
            • General requirements<\/li>\n\n\n\n
            • Design and manufacturing requirements <\/li>\n\n\n\n
            • Requirements relative to information provided with the device<\/li>\n<\/ul>\n<\/li>\n\n\n\n
            • 4. Summary\/Q&A<\/li>\n\n\n\n
            • 5. 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. RL22 – INTRA \/ INTER EUROPEAN REGULATIONS COURSE DESCRIPTION To place Medical Devices on the market in Europe, the requirements of Regulation (EU) 2017\/745 must be met. The manufacturer must design and manufacture its devices so as to ensure that, under normal conditions of use, they are suited for their intended use, safe and […]<\/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\/540"}],"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=540"}],"version-history":[{"count":1,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/540\/revisions"}],"predecessor-version":[{"id":541,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/540\/revisions\/541"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=540"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=540"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=540"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}