{"id":665,"date":"2023-04-25T17:30:06","date_gmt":"2023-04-25T15:30:06","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=665"},"modified":"2023-06-16T16:24:36","modified_gmt":"2023-06-16T14:24:36","slug":"package-for-research-development","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/e-learning\/package-for-research-development\/","title":{"rendered":"E-MDR-F-06 – Package for RESEARCH & DEVELOPMENT"},"content":{"rendered":"\n
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REF. E-MDR-F-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 RESEARCH & DEVELOPMENT package is composed of 6 modules and has been designed specifically to present, in an interactive format, the main obligations of the R&D Department to ensure compliance with Regulation (EU) 2017\/745.<\/p>\n<\/div><\/div>\n\n\n\n

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

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

185 minutes, including 120 minutes of lessons and 65 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 modules are composed of lessons in the form of interactive videos with voice-off and learning activities. They 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, and more particularly the R&D Department<\/p>\n<\/div><\/div>\n\n\n\n

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

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

Familiarity with the MD sector<\/p>\n<\/div><\/div>\n\n\n\n

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

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

The CEISO ACADEMY platform can be accessed for a period of four 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
\n

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 regulatory framework for medical devices<\/li>\n\n\n\n
  • Identify the requirements that apply and their impact on research and development activities.<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
    <\/div>\n\n\n\n
    \n

    COURSE CONTENT<\/h2>\n\n\n\n
      \n
    1. Overview of Regulation (EU) 2017\/745<\/li>\n\n\n\n
    2. Obligations of economic operators<\/li>\n\n\n\n
    3. EUDAMED & UDI<\/li>\n\n\n\n
    4. Classification of Medical Devices<\/li>\n\n\n\n
    5. General Safety and Performance Requirements<\/li>\n\n\n\n
    6. Technical Documentation<\/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 package is assessed based on each individual\u2019s acquisition of knowledge via a quiz at the end of each module (practice quiz) <\/em> and one at the end of the 6 modules (final quiz\/success criteria >= 80%). <\/em>When trainees pass the final 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-F-06 \u2013 E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017\/745 COURSE DESCRIPTION The RESEARCH & DEVELOPMENT package is composed of 6 modules and has been designed specifically to present, in an interactive format, the main obligations of the R&D Department to ensure compliance with Regulation (EU) 2017\/745. DURATION 185 minutes, including 120 minutes of lessons and […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[8,9],"tags":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/665"}],"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=665"}],"version-history":[{"count":2,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/665\/revisions"}],"predecessor-version":[{"id":741,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/665\/revisions\/741"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=665"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=665"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=665"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}