{"id":466,"date":"2023-04-25T09:55:50","date_gmt":"2023-04-25T07:55:50","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=466"},"modified":"2023-04-25T09:55:51","modified_gmt":"2023-04-25T07:55:51","slug":"gr03-medical-device-software-development","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/regulatory-quality-trainings\/gr03-medical-device-software-development\/","title":{"rendered":"GR03 – Medical Device Software Development"},"content":{"rendered":"\n
\n

REF. GR03 – INTRA \/ INTER<\/p>\n\n\n\n

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

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

At the end of this course, participants will understand the concepts set out in EN 62304:2006\/AC 2008\/A1:2015 regarding software development and better grasp the regulatory and normative requirements governing market authorization for medical devices (MD) with incorporated software or stand-alone software as a medical device in Europe. They will also be able to identify the documentary deliverables required based on the Software Safety Classification.<\/p>\n<\/div><\/div>\n\n\n\n

<\/div>\n\n\n\n
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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 regulatory requirements for MD software<\/li>\n\n\n\n
  • Understand the specificities of the different types of software, which implies a thorough understanding of their development<\/li>\n\n\n\n
  • Distinguish and understand the ties between the Analysis and Management of MD Risks and the Software Safety Classification<\/li>\n\n\n\n
  • Identify the normative requirements for the development of MD software<\/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: <\/p>\n\n\n\n

      \n
    • R&D Manager<\/li>\n\n\n\n
    • Software Development Manager and any individual who works on the development of software and\/or MD design\/development<\/li>\n\n\n\n
    • The individual responsible for ensuring compliance with the regulations<\/li>\n\n\n\n
    • Quality Manager<\/li>\n\n\n\n
    • Regulatory Affairs Manager<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
      <\/div>\n\n\n\n
      \n

      PREREQUISITES<\/h2>\n\n\n\n
        \n
      • Familiarity with the MD sector<\/li>\n\n\n\n
      • Familiarity with software concepts<\/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
        • Case studies<\/li>\n\n\n\n
        • Reference to Regulation (EU) 2017\/745<\/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 check that they are achieved:<\/strong><\/p>\n\n\n\n

            \n
          1. Identify regulatory requirements for MD software<\/li>\n\n\n\n
          2. Understand the specificities of the different types of software, which implies a thorough understanding of their development\n
              \n
            • Stand-Alone Software<\/li>\n\n\n\n
            • Software embedded in a microprocessor or microcontroller<\/li>\n\n\n\n
            • Software embedded in another component (firmware)<\/li>\n<\/ul>\n<\/li>\n\n\n\n
            • Distinguish and understand the ties between the Analysis and Management of MD Risks and the Software Safety Classification according to EN 62304<\/li>\n\n\n\n
            • MD software development process<\/li>\n\n\n\n
            • Summary\/Q&A<\/li>\n\n\n\n
            • Training 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. GR03 – INTRA \/ INTER MANAGING RISKS COURSE DESCRIPTION At the end of this course, participants will understand the concepts set out in EN 62304:2006\/AC 2008\/A1:2015 regarding software development and better grasp the regulatory and normative requirements governing market authorization for medical devices (MD) with incorporated software or stand-alone software as a medical device […]<\/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\/466"}],"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=466"}],"version-history":[{"count":1,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/466\/revisions"}],"predecessor-version":[{"id":467,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/466\/revisions\/467"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=466"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=466"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=466"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}