Question 1
Under FDA 21 CFR 820, which document contains the complete set of records for a specific production unit of a medical device?
Correct Answer:
Device History Record (DHR)
Question 2
Which regulatory framework replaced the Medical Device Directives (MDD) in the European Union?
Correct Answer:
EU MDR 2017/745
Question 3
What is the primary purpose of ISO 13485:2016 in the medical device industry?
Correct Answer:
To specify requirements for a quality management system for medical device organizations
Question 4
Which countries participate in the Medical Device Single Audit Program (MDSAP)?
Correct Answer:
USA, Canada, Brazil, Japan, and Australia
Question 5
According to FDA 21 CFR 820, what must a manufacturer establish and maintain to ensure purchased or otherwise received product and services conform to specified requirements?
Correct Answer:
Purchasing controls
Question 1
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About this Exam

Prepare with the CMDA Practice Questions - Certified Medical Device Auditor Exam practice quiz. This question bank includes 100 questions covering device, medical, audit, auditor, and design. Use it to review important concepts, identify knowledge gaps, and build confidence for the related exam, course, or assessment.

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CMDA Practice Questions - Certified Medical Device Auditor Exam

This practice set contains 100 questions from the matching question bank and focuses on device, medical, audit, auditor, and design. Work through each question carefully, review the provided solutions, and revisit topics that need more study before your next attempt.

This is an independent study resource intended for practice and review; it is not an official examination or an endorsement by any organization named in the title.

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