{"id":644,"date":"2023-04-25T16:39:58","date_gmt":"2023-04-25T14:39:58","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=644"},"modified":"2023-06-16T16:32:05","modified_gmt":"2023-06-16T14:32:05","slug":"post-market-surveillance-vigilance","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/e-learning\/post-market-surveillance-vigilance\/","title":{"rendered":"E-MDR-MOD-10 – Post-Market Surveillance & Vigilance"},"content":{"rendered":"\n
\n

REF. E-MDR-MOD-10 \u2013 E-LEARNING<\/p>\n\n\n\n

EUROPEAN REGULATIONS<\/p>\n\n\n\n

REGULATION (EU) 2017\/745<\/p>\n<\/div><\/div>\n\n\n\n

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

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

The Post-Market Surveillance & Vigilance module describes the purpose of post-market surveillance and the procedures to implement based on the type of data collected.<\/p>\n<\/div><\/div>\n\n\n\n

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

DURATION<\/h3>\n\t\t

30 minutes, including a 20-minute lesson and 10 minutes of quizzes<\/p>\n\t<\/div>\n\t

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

E-LEARNING<\/h3>\n\t<\/div>\n
\n\t\t

TECHNICAL PREREQUISITES<\/h3>\n\t\t

Computer and internet connection<\/p>\n\t<\/div>\n<\/div>\n\n\n\n

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

METHODS USED<\/h2>\n\n\n\n

The module is composed of a lesson in the form of an interactive video with voice-off and learning activities. The module can be accessed 24\/7. Reminders are sent to monitor knowledge acquisition and avoid a break in the learning curve.<\/p>\n<\/div><\/div>\n\n\n\n

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

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

All individuals involved in the MD sector<\/p>\n<\/div><\/div>\n\n\n\n

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

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

Knowledge of the Regulation\u2019s main definitions and general principles, more particularly those regarding product classification and the principles to demonstrate and monitor clinical benefits (N.B. covered in the Overview, MD Classification and Clinical Evaluation modules)<\/p>\n<\/div><\/div>\n\n\n\n

<\/div>\n\n\n\n
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ACCESS<\/h2>\n\n\n\n

The CEISO ACADEMY platform can be accessed for a period of two months within two business days at most of approval of your order.<\/p>\n<\/div><\/div>\n\n\n\n

<\/div>\n\n\n\n
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ADDITIONAL BENEFITS<\/h2>\n\n\n\n

Summary presentation of the regulation<\/p>\n\n\n\n

Support materials designed by experienced consultants-trainers<\/p>\n\n\n\n

Interactive lesson<\/p>\n\n\n\n

Short modules that can be accessed as often as required and autonomously<\/p>\n\n\n\n

As an option, you may select Q&A sessions with one of our consultants-trainers<\/p>\n<\/div><\/div>\n\n\n\n

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

EDUCATIONAL GOALS<\/h2>\n\n\n\n
    \n
  • Understand the need for post-market surveillance<\/li>\n\n\n\n
  • Become familiar with the procedures to apply based on the type of data collected<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
    <\/div>\n\n\n\n
    \n

    COURSE CONTENT<\/h2>\n\n\n\n

    Assistance with navigation\/Module objectives\/Presentation of the course content<\/strong><\/p>\n\n\n\n

      \n
    1. Post-market surveillance (PMS)<\/li>\n\n\n\n
    2. Claim processing<\/li>\n\n\n\n
    3. Vigilance<\/li>\n\n\n\n
    4. Processing other relevant information<\/li>\n\n\n\n
    5. Post-market clinical follow-up (PMCF)<\/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 each individual\u2019s acquisition of knowledge via a quiz at the end of the program (success criteria >= 80%).<\/em> If trainees pass the quiz, they receive their training certificate, as well as the corrected quiz, by email.<\/em><\/p>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

        REF. E-MDR-MOD-10 \u2013 E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017\/745 COURSE DESCRIPTION The Post-Market Surveillance & Vigilance module describes the purpose of post-market surveillance and the procedures to implement based on the type of data collected. DURATION 30 minutes, including a 20-minute lesson and 10 minutes of quizzes E-LEARNING TECHNICAL PREREQUISITES Computer and internet connection METHODS […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[8,10],"tags":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/644"}],"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=644"}],"version-history":[{"count":2,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/644\/revisions"}],"predecessor-version":[{"id":760,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/644\/revisions\/760"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=644"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=644"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=644"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}