{"id":463,"date":"2023-04-25T09:51:49","date_gmt":"2023-04-25T07:51:49","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=463"},"modified":"2023-04-25T09:51:50","modified_gmt":"2023-04-25T07:51:50","slug":"gr02-medical-devices-risk-management","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/regulatory-quality-trainings\/gr02-medical-devices-risk-management\/","title":{"rendered":"GR02 – Medical Devices: Risk Management"},"content":{"rendered":"\n
\n

REF. GR02 – INTRA \/ INTER<\/p>\n\n\n\n

MANAGING RISKS<\/p>\n<\/div><\/div>\n\n\n\n

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

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

This training will allow you to update or acquire practical knowledge to identify and manage risks related to the use of medical devices in accordance with the recommendations set out in ISO 14971:2019<\/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
  • Become familiar with the terms and vocabulary<\/li>\n\n\n\n
  • Identify what is new in the 2019 version compared to the 2012 version<\/li>\n\n\n\n
  • Become familiar with the risk management methodology described in the standard<\/li>\n\n\n\n
  • Raise the awareness of all parties involved to ensure effective risk management<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
    <\/div>\n\n\n\n
    \n

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

    MD manufacturers, and more particularly:\u00a0<\/p>\n\n\n\n

      \n
    • Quality\/Regulatory Affairs Manager<\/li>\n\n\n\n
    • R&D team<\/li>\n\n\n\n
    • Manufacturing Manager<\/li>\n\n\n\n
    • Product Leader<\/li>\n\n\n\n
    • Sales Representative<\/li>\n\n\n\n
    • Technical Director<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
      <\/div>\n\n\n\n
      \n

      PREREQUISITES<\/h2>\n\n\n\n
        \n
      • General knowledge of the regulatory framework for MDs and\/or IVDMDs <\/li>\n\n\n\n
      • Some knowledge of risk management (EN ISO 14971 version 2012)<\/li>\n\n\n\n
      • Some knowledge of CE marking requirements in terms of Technical Documentation<\/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
        • Tailored examples – group exercises<\/li>\n\n\n\n
        • Reference to Regulation (UE ) 2017\/745 and EN ISO 14971<\/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\/Presentation of the course objectives and method to ensure that they are achieved:<\/strong><\/p>\n\n\n\n

            \n
          1. Regulatory requirements: a review<\/li>\n\n\n\n
          2. ISO 14971:2012 compared to ISO 14971:2019\n
              \n
            1. General risk management principles according to EN ISO 14971<\/li>\n\n\n\n
            2. Scope<\/li>\n\n\n\n
            3. Definitions<\/li>\n\n\n\n
            4. Risk management process<\/li>\n\n\n\n
            5. Personnel skills<\/li>\n\n\n\n
            6. Risk management plan<\/li>\n\n\n\n
            7. Risk analysis – Evaluation – Control<\/li>\n\n\n\n
            8. Overall residual risk<\/li>\n\n\n\n
            9. \u201cProduction and Post-Production\u201d activities<\/li>\n<\/ol>\n<\/li>\n\n\n\n
            10. Summary\/Q&A<\/li>\n\n\n\n
            11. Course evaluation and conclusion<\/li>\n<\/ol>\n\n\n\n

              Virtual classroom training: the course can be divided into two half-days<\/em>.<\/p>\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. GR02 – INTRA \/ INTER MANAGING RISKS COURSE DESCRIPTION This training will allow you to update or acquire practical knowledge to identify and manage risks related to the use of medical devices in accordance with the recommendations set out in ISO 14971:2019 OBJECTIVES TARGET TRAINEES MD manufacturers, and more particularly:\u00a0 PREREQUISITES TRAINING RESOURCES COURSE […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[16,13],"tags":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/463"}],"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=463"}],"version-history":[{"count":1,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/463\/revisions"}],"predecessor-version":[{"id":464,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/463\/revisions\/464"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=463"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=463"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=463"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}