Question 1

How many CMDA practice questions are there?

Accepted Answer

135 questions across 1 version, each with the correct answer and an explanation.

Question 2

Are there free CMDA sample questions?

Accepted Answer

Yes. 12 sample questions are free; 6 are open to everyone and the rest unlock with a free account.

Question 3

What does full access include?

Accepted Answer

Every CMDA question in study, timed and flashcard modes, explanations for each answer, and progress that saves so you can resume.

Question 4

What topics does CMDA cover?

Accepted Answer

Auditing Fundamentals (8.9%), Auditing and Inspection Processes (20.7%), Medical Device Quality Management System Requirements (28.2%), Technical Medical Device Knowledge (31.1%), Quality Tools and Techniques (11.1%).

Question 5

What is the ASQ CMDA certification?

Accepted Answer

The ASQ Certified Medical Device Auditor (CMDA) certification validates a professional's knowledge and ability to audit medical device quality management systems. It covers auditing fundamentals, FDA regulations (21 CFR 820), EU MDR 2017/745, ISO 13485, risk management (ISO 14971), sterilization processes, design controls, and quality tools. Formerly known as the Certified Biomedical Auditor (CBA), the CMDA is recognized globally as a benchmark for medical device auditing competence.

Question 6

How much does the ASQ CMDA exam cost?

Accepted Answer

The ASQ CMDA exam costs $450 for ASQ members and $550 for non-members. Retakes are available at a reduced rate of $350. ASQ membership provides a $100 discount on the initial examination fee, making membership a cost-effective option for certification candidates.

Question 7

What are the experience requirements for the ASQ CMDA?

Accepted Answer

Candidates need 5 years of on-the-job experience in one or more areas of the CMDA Body of Knowledge, with at least 1 year in a decision-making position. Education waivers are available: an associate degree waives 1 year, a bachelor's degree waives 3 years, and a master's or doctorate waives 4 years of the experience requirement. Only one education waiver may be claimed.

Question 8

Is the ASQ CMDA exam open book?

Accepted Answer

Yes, the ASQ CMDA exam is open book. Candidates may bring bound reference materials including textbooks, standards, and notes. All materials must be permanently bound or securely fastened in covers (ring binders, spiral binders, etc.). Hand-stapled documents and loose materials are not allowed. The official CMDA Handbook (4th edition by Scott Laman) is a popular reference to bring to the exam.

Question 9

What is the passing score for the ASQ CMDA exam?

Accepted Answer

The passing score for the ASQ CMDA exam is 550 out of 750. The exam consists of 145 multiple-choice questions, of which 135 are scored and 10 are unscored pretest items. For computer-based testing, candidates receive their results immediately after submitting the exam, with email confirmation within 3-5 business days.

Question 10

How do I maintain my ASQ CMDA certification?

Accepted Answer

The CMDA certification is valid for 3 years and can be maintained by earning 18 Recertification Units (RUs) through professional development activities such as continuing education, employment in the field, teaching, publishing, or committee work. Alternatively, you can retake and pass the current exam. There is a 60-day grace period after the recertification date to submit RUs; after that, you must recertify by exam within 1 year or the certification expires.

Question 11

What is the difference between the ASQ CMDA and CQA certifications?

Accepted Answer

The ASQ CMDA (Certified Medical Device Auditor) focuses specifically on medical device quality system auditing, covering FDA regulations (21 CFR 820), EU MDR 2017/745, ISO 13485, risk management, sterilization, and device-specific technical knowledge. The CQA (Certified Quality Auditor) is a general quality auditing certification applicable across industries. The CMDA was created by combining the former CQA-Biomedical Body of Knowledge with fundamental auditing skills, so CMDA candidates no…

Question 12

What topics does the ASQ CMDA exam cover?

Accepted Answer

The CMDA exam covers five main domains: (1) Auditing Fundamentals (12 questions) including audit types, roles, and ethics; (2) Auditing and Inspection Processes (28 questions) covering audit planning, performance, reporting, and CAPA; (3) Medical Device QMS Requirements (38 questions) including FDA 21 CFR 820, EU MDR, ISO 13485, and post-market surveillance; (4) Technical Medical Device Knowledge (42 questions) covering risk management, design controls, sterilization, software, and validation;…

Question 13

How does the FDA QMSR transition affect the CMDA exam?

Accepted Answer

The FDA's Quality Management System Regulation (QMSR), effective February 2, 2026, replaces the traditional 21 CFR 820 Quality System Regulation (QSR) by incorporating ISO 13485:2016 by reference. This means medical device auditors must understand both the historical QSR framework and the new QMSR alignment with ISO 13485. The CMDA exam Body of Knowledge will likely be updated to reflect this significant regulatory change, making familiarity with both frameworks essential for exam candidates.

Question 14

What study materials are recommended for the ASQ CMDA exam?

Accepted Answer

The top recommended resources include: (1) The ASQ Certified Medical Device Auditor Handbook, 4th Edition by Scott Laman - the primary reference aligned with the Body of Knowledge; (2) The CMDA Question Bank from ASQ with 3 sets of 135 practice questions each; (3) FDA 21 CFR 820 (QSR/QMSR) and related regulations; (4) ISO 13485:2016, ISO 14971:2019, and IEC 62304; (5) The ASQ 3-day CMDA Certification Preparation course. Since the exam is open book, bringing well-tabbed reference materials is…

CMDAASQ Certified Medical Device Auditor practice test

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Practice CMDA in the simulator.

CMDA, by the numbers.

Everything about CMDA.

Exam information

What CMDA covers

How do I earn this certification?

How to study for this exam?

What's changed on this exam?

Who should take this exam?

Three ways to practise

Study mode

Timed mode

Flashcards

CMDA questions, answered

CMDAASQ Certified Medical Device Auditor practice test

Full access

Practice CMDA in the simulator.

CMDA, by the numbers.

Everything about CMDA.

Exam information

01Exam format258 min · 1455

02RegistrationPrometric, online proctoring2

03Validity3 years2

04In our question bankv1 (135)

What CMDA covers

01Auditing Fundamentals8.9%3 topics

1.BAudit Roles and ResponsibilitiesExplain key functions and responsibilities of various audit participants including audit team members, lead auditor, client, auditee, etc.2 obj.

1.CEthical, Legal, and Professional IssuesDefine and apply the ASQ Code of Ethics, concepts of due diligence and due care with respect to confidentiality and conflict of interest4 obj.

Hands-on skills & common mistakesClassifying audit types by purpose and method · Confusing first-party, second-party, and third-party audit classifications

02Auditing and Inspection Processes20.7%5 topics

03Medical Device Quality Management System Requirements28.2%5 topics

04Technical Medical Device Knowledge31.1%11 topics

05Quality Tools and Techniques11.1%3 topics

How do I earn this certification?

01PrerequisitesCQA1

02Current levelCMDA1

03Next level optionsCMQ-OE1

04Alternative pathsCFSQA, CCQM2