{"id":446,"date":"2023-04-24T17:23:12","date_gmt":"2023-04-24T15:23:12","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=446"},"modified":"2023-04-24T17:23:12","modified_gmt":"2023-04-24T15:23:12","slug":"cl08-clinical-performance-evaluation-of-an-in-vitro-diagnostic-medical-device","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/clinical-trainings\/cl08-clinical-performance-evaluation-of-an-in-vitro-diagnostic-medical-device\/","title":{"rendered":"CL08 – Clinical Performance Evaluation of an In Vitro Diagnostic Medical Device"},"content":{"rendered":"\n
\n

REF. CL08 – INTRA \/ INTER<\/p>\n\n\n\n

CLINICAL<\/p>\n<\/div><\/div>\n\n\n\n

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

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

The demonstration of the compliance of an In Vitro<\/em> Diagnostic Medical Device (IVDMD) with the general requirements of Regulation (EU) 2017\/746 may include a performance evaluation intended to establish or verify the scientific validity and clinical performance of a device.<\/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\/746 in terms of the performance evaluation<\/li>\n\n\n\n
  • Become familiar with the basics to draft a performance evaluation report<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
    <\/div>\n\n\n\n
    \n

    TARGET TRAINEES<\/h2>\n\n\n\n
      \n
    • Manufacturers of In Vitro<\/em> Diagnostic Medical Devices <\/em><\/li>\n\n\n\n
    • IVDMD 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

      Familiarity with the Medical Device regulation<\/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
      • Examples tailored to the company\u2019s products<\/li>\n\n\n\n
      • Distribution of the texts presented<\/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. Context and definitions\n
            \n
          • Terms and definitions<\/li>\n\n\n\n
          • Regulation (EU) 2017\/746 requirements<\/li>\n<\/ul>\n<\/li>\n\n\n\n
          • Evaluation of the performance of an IVDMD\n
              \n
            • The different characteristics<\/li>\n\n\n\n
            • Documents to be prepared<\/li>\n<\/ul>\n<\/li>\n\n\n\n
            • Performance evaluation report\n
                \n
              • Composition<\/li>\n\n\n\n
              • Goals targeted<\/li>\n\n\n\n
              • The different sections of the Performance Evaluation Report: What data? How to analyze it?<\/li>\n<\/ul>\n<\/li>\n\n\n\n
              • Literature review methodology\n
                  \n
                • The different sources of information<\/li>\n\n\n\n
                • Selection and critical evaluation of the literature\u2019s data<\/li>\n\n\n\n
                • Data analysis to establish the state of the art or the clinical performance of an IVDMD<\/li>\n<\/ul>\n<\/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 >= 80%).<\/em><\/p>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

                    REF. CL08 – INTRA \/ INTER CLINICAL COURSE DESCRIPTION The demonstration of the compliance of an In Vitro Diagnostic Medical Device (IVDMD) with the general requirements of Regulation (EU) 2017\/746 may include a performance evaluation intended to establish or verify the scientific validity and clinical performance of a device. OBJECTIVES TARGET TRAINEES PREREQUISITES Familiarity with […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[12],"tags":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/446"}],"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=446"}],"version-history":[{"count":1,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/446\/revisions"}],"predecessor-version":[{"id":448,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/446\/revisions\/448"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=446"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=446"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=446"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}