{"id":635,"date":"2023-04-25T16:32:17","date_gmt":"2023-04-25T14:32:17","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=635"},"modified":"2023-06-16T16:29:50","modified_gmt":"2023-06-16T14:29:50","slug":"general-safety-and-performance-requirements","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/e-learning\/general-safety-and-performance-requirements\/","title":{"rendered":"E-MDR-MOD-07 – General Safety and Performance Requirements"},"content":{"rendered":"\n
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REF. E-MDR-MOD-07 \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
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COURSE DESCRIPTION<\/h2>\n\n\n\n

The General Safety and Performance Requirements (GSPR) module presents the safety and performance, design and manufacturing requirements and the information that must be provided with a Medical Device (MD).<\/p>\n<\/div><\/div>\n\n\n\n

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

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

37 minutes, including a 25-minute lesson and 12 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
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PREREQUISITES<\/h2>\n\n\n\n

Knowledge of the Regulation\u2019s main definitions and general principles (N.B. covered in the Overview module)<\/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
  • Become familiar with the safety and performance requirements set out in Annex I of the Regulation<\/li>\n\n\n\n
  • Differentiate the general requirements from those regarding performance, design and manufacturing<\/li>\n\n\n\n
  • Be aware of the information to be provided with an MD<\/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. General requirements<\/li>\n\n\n\n
    2. Performance, design and manufacturing requirements<\/li>\n\n\n\n
    3. Requirements relative to information provided with the device<\/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-07 \u2013 E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017\/745 COURSE DESCRIPTION The General Safety and Performance Requirements (GSPR) module presents the safety and performance, design and manufacturing requirements and the information that must be provided with a Medical Device (MD). DURATION 37 minutes, including a 25-minute lesson and 12 minutes of quizzes E-LEARNING TECHNICAL PREREQUISITES […]<\/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\/635"}],"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=635"}],"version-history":[{"count":3,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/635\/revisions"}],"predecessor-version":[{"id":754,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/635\/revisions\/754"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=635"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=635"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=635"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}