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Key Facts: CMDA Exam
150
Exam Questions
ASQ
$418/$568
Exam Fee (Member/Non)
ASQ
4.5 hrs
Time Limit
ASQ
Open Book
Exam Format
ASQ
The CMDA is ASQ's specialized certification for auditors in the medical device industry. It validates competence in auditing against ISO 13485, FDA 21 CFR Part 820, and other regulatory frameworks governing medical devices. CMDA holders conduct internal, supplier, and third-party audits to ensure medical device manufacturers maintain compliant quality management systems.
About the CMDA Exam
The CMDA certification from ASQ validates expertise in auditing medical device quality management systems, including ISO 13485, FDA QSR, and regulatory compliance.
Questions
150 scored questions
Time Limit
4.5 hours
Passing Score
Pass/Fail (scaled)
Exam Fee
$418/$568 (ASQ)
CMDA Exam Content Outline
Regulatory Framework
FDA QSR (21 CFR 820), EU MDR, ISO 13485, and global medical device regulatory requirements
Medical Device Quality Systems
Design controls, production controls, CAPA, risk management (ISO 14971), and complaint handling
Audit Process
Audit planning, execution, evidence evaluation, nonconformity classification, and reporting
Product Realization & Lifecycle
Design and development, purchasing controls, process validation, and post-market surveillance
How to Pass the CMDA Exam
What You Need to Know
- Passing score: Pass/Fail (scaled)
- Exam length: 150 questions
- Time limit: 4.5 hours
- Exam fee: $418/$568
Keys to Passing
- Complete 500+ practice questions
- Score 80%+ consistently before scheduling
- Focus on highest-weighted sections
- Use our AI tutor for tough concepts
CMDA Study Tips from Top Performers
Frequently Asked Questions
What is the CMDA exam?
The CMDA (Certified Medical Device Auditor) is ASQ's certification for professionals who audit medical device quality management systems. It covers ISO 13485, FDA QSR, EU MDR, audit methodology, and medical device regulatory compliance.
How many questions are on the CMDA exam?
The CMDA exam has 150 multiple-choice questions to be completed in 4.5 hours. The exam is open-book and administered at Pearson VUE testing centers worldwide.
What is the CMDA passing score?
The CMDA uses a scaled scoring system with a Pass/Fail result. ASQ does not publish the exact cut score. The exam tests both auditing methodology and medical device regulatory knowledge.
What experience is needed for the CMDA?
CMDA candidates need 8 years of experience in medical device quality or auditing. A degree offsets some experience: a bachelor's counts as 4 years, a master's as 5 years. At least 3 years must involve medical device auditing activities.
What is the difference between CMDA and CQA?
The CMDA is specifically designed for medical device auditing, covering ISO 13485, FDA QSR, and EU MDR regulations. The CQA (Certified Quality Auditor) is a general audit certification applicable across all industries without medical device-specific regulatory content.