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?

Reduced time required for regulatory audits (C) Signup and view all the answers

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

To ensure compliance with MDSAP audit criteria requirements (A) Signup and view all the answers

What does IMDRF MDSAP WG N11 document?

Nonconformities resulting from a Regulatory Authority assessment (A) Signup and view all the answers

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

Competency and training requirements for auditing organizations (A) Signup and view all the answers

Who comprises the IMDRF Management Committee?

Regulatory authority representatives from Australia, Brazil, Canada, China, Europe, Japan, Russia, and United States of America (D) Signup and view all the answers

What was the purpose of creating the IMDRF in 2011?

To accelerate international medical device regulatory harmonization and convergence (D) Signup and view all the answers

What role does the IMDRF Chair play?

The chair is responsible for leading the IMDRF Management Committee and its activities (D) Signup and view all the answers

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