IMDRF Working Groups and Affiliates Quiz
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Questions and Answers

What is the role of the Oversees Working Groups formed with experts from various stakeholder?

  • Promoting medical devices to the general public
  • Developing technical documents for the medical device industry (correct)
  • Conducting clinical trials for medical devices
  • Regulating the pricing of medical devices

    • Which organizations serve as IMDRF Official Observers?

  • The World Health Organization (WHO) and the APEC LSIF Regulatory Harmonization Steering Committee (correct)
  • The United Nations and the World Trade Organization
  • The World Health Organization (WHO) and the International Red Cross
  • The European Union and the American Medical Association

    • What is the purpose of the Medical Device Single Audit Program (MDSAP)?

  • Developing global guidelines for medical device manufacturing
  • Regulating the international trade of medical devices
  • Allowing a single regulatory audit of a medical device manufacturer’s quality management system (correct)
  • Conducting multiple regulatory audits for a single medical device manufacturer

    • What is the main benefit of MDSAP for medical device manufacturers?

    <p>Reduced time required for regulatory audits</p> Signup and view all the answers

    What is the purpose of continuous gap assessments recommended for medical device manufacturers?

    <p>To ensure compliance with MDSAP audit criteria requirements</p> Signup and view all the answers

    What does IMDRF MDSAP WG N11 document?

    <p>Nonconformities resulting from a Regulatory Authority assessment</p> Signup and view all the answers

    What is the significance of the IMDRF MDSAP WG N3 document?

    <p>Competency and training requirements for auditing organizations</p> Signup and view all the answers

    Who comprises the IMDRF Management Committee?

    <p>Regulatory authority representatives from Australia, Brazil, Canada, China, Europe, Japan, Russia, and United States of America</p> Signup and view all the answers

    What was the purpose of creating the IMDRF in 2011?

    <p>To accelerate international medical device regulatory harmonization and convergence</p> Signup and view all the answers

    What role does the IMDRF Chair play?

    <p>The chair is responsible for leading the IMDRF Management Committee and its activities</p> Signup and view all the answers

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