{"id":627,"date":"2023-04-25T16:26:00","date_gmt":"2023-04-25T14:26:00","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=627"},"modified":"2023-06-16T16:29:27","modified_gmt":"2023-06-16T14:29:27","slug":"conformity-assessment","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/e-learning\/conformity-assessment\/","title":{"rendered":"E-MDR-MOD-06 – Conformity Assessment"},"content":{"rendered":"\n
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REF. E-MDR-MOD-06 \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 Conformity Assessment module presents the procedures to assess conformity and the Technical Documentation\u2019s sampling principles in the framework of this assessment.<\/p>\n<\/div><\/div>\n\n\n\n

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

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

16 minutes, including a 10-minute lesson and 6 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
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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
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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

Familiarity with the Regulation\u2019s main definitions and general principles, more particularly regarding market authorization, as well as classification and UDI rules (N.B. covered in the Overview, EUDAMED and UDI, Market Authorization and MD Classification 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
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EDUCATIONAL GOALS<\/h2>\n\n\n\n
    \n
  • Understand the conformity assessment procedures for medical devices according to Regulation (EU) 2017\/745<\/li>\n\n\n\n
  • Understand the Technical Documentation\u2019s sampling principles in the framework of Medical Device conformity assessments<\/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. Preamble<\/li>\n\n\n\n
    2. Conformity assessment procedures<\/li>\n\n\n\n
    3. Technical Documentation assessment via sampling<\/li>\n\n\n\n
    4. Quality Management System evaluation<\/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-06 \u2013 E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017\/745 COURSE DESCRIPTION The Conformity Assessment module presents the procedures to assess conformity and the Technical Documentation\u2019s sampling principles in the framework of this assessment. DURATION 16 minutes, including a 10-minute lesson and 6 minutes of quizzes E-LEARNING TECHNICAL PREREQUISITES Computer and internet connection METHODS USED The […]<\/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\/627"}],"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=627"}],"version-history":[{"count":2,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/627\/revisions"}],"predecessor-version":[{"id":752,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/627\/revisions\/752"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=627"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=627"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=627"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}