Certified Medical Device Auditor (CMDA): 6 Practice Tests

Becoming a skilled medical‑device auditor demands far more than memorizing clauses-it requires a systematic grasp of audit science, device regulations, and real‑world risk management. This course blends six full‑length practice exams with guided explanations to help you internalize every competency the industry expects. 1.

Auditing FundamentalsWe start with the full audit life‑cycle-planning, conducting, reporting, follow‑up-then drill into evidence sampling, audit objectives, scope, criteria, and the soft skills that set great auditors apart: clear communication, ethical judgment, and effective opening/closing meetings. 2. Audit Tools and TechniquesYou will practice building document‑review checklists, tracing requirements through matrices, interviewing personnel at every level, and using root‑cause tools such as the 5 Whys and Ishikawa diagrams.

Flowcharts, Pareto analysis, and basic control‑chart interpretation round out your quantitative toolkit. 3. Medical Device Fundamentals & Regulatory FrameworkWe map the device lifecycle from concept to post‑market, decode global classifications (US Class I/II/III, EU risk classes), and cover UDI, labeling, and packaging rules.

Deep dives into ISO 13485, ISO 14971, ISO 10993 plus FDA 21 CFR 820/803/806, EU MDR 2017/745, and IVDR ensure you can cite-and audit against-every critical requirement. 4. Quality Management SystemsBuilding on the standards above, this module dissects ISO 13485 clauses, document controls, risk‑based thinking, CAPA systems, management review, process validation, and internal audit programs.