ASQ Medical Device Auditor Sample Questions

Updated on 19 September 2026. What’s new: CMDA exam fees corrected, and the syllabus moved to ASQ's 2026 Body of Knowledge.

To earn the ASQ Certified Medical Device Auditor (CMDA) certification, you need five years of relevant experience (one in a decision-making role, with degree waivers), then pass one open-book exam of 145 multiple-choice questions in 258 minutes with a score of 550/750. From the November 2026 testing window, ASQ tests the new 2026 CMDA Body of Knowledge, so study from the 2026 BoK.

Want to see how ready you are today? Take a timed CMDA practice exam built on the same 145-question format.

The medical device industry runs on evidence. Every design decision, supplier approval, sterilization cycle and complaint investigation has to be documented, reviewed and defensible in front of a regulator or a notified body. The people who test whether that evidence holds up are auditors, and the ASQ CMDA credential is the one that proves an auditor understands both the auditing craft and the medical device rules behind it.

This guide takes you from the first question, whether you are eligible, to the last one, what to do in the exam room. It covers the exam facts, what changed in the 2026 Body of Knowledge, what each of the five domains asks of you, a preparation plan, the mistakes that cost candidates the most marks, and how the credential helps your career.