Latest ASQ CMDA Exam Questions and Answers 2025 | Pass Certified Medical Device Auditor Certification Exam!

I. Auditing Fundamentals (12 Questions)
A. Types of Audits
B. Audit Roles and Responsibilities
C. Ethical, Legal, and Professional Issues

II. Auditing and Inspection Processes (28 Questions)
A. Audit Preparation and Planning
B. Audit Performance
C. Audit Report
D. Audit Follow-Up and Closure
E. Audit Procedural References

III. Medical Device Quality Management System Requirements (38 Questions)
A. Regulatory Laws and Requirements
B. In Vitro Diagnostic (IVD) Devices
C. International Quality System Standards
D. Quality System Regulation (QSR)
E. Post-Market Surveillance

IV. Technical Medical Device Knowledge (42 Questions)
A. Risk Management
B. Design Control
C. Software Development & Maintenance
D. Labeling Requirements
E. Controlled Environments & Utilities
F. Sterile Device Processes
G. Laboratory Testing & Failure Analysis

V. Quality Tools and Techniques (15 Questions)
A. Quality Control & Problem-Solving Tools
B. Process Improvement Techniques
C. Data Types & Sampling Methods

SPOTO's CMDA dumps feature a rich collection of real-world audit scenarios and multiple-choice questions that span every domain of the Body of Knowledge. Authored and peer-reviewed by seasoned medical-device auditors, our bank mimics the format and complexity of the live 145-question exam—ensuring you gain hands-on familiarity with audit checklists, reporting formats, and regulatory references. With over twice as many practice items as the actual exam, you'll reinforce your understanding of audit fundamentals, technical device standards, and quality-system requirements in just 7-10 days.

SPOTO delivers the most accurate, up-to-date CMDA exam materials on the market. Our full-length mock exams mirror the 270-minute, open-book format, while every answer is accompanied by detailed rationales grounded in FDA, ISO 13485, and global regulatory guidelines. Personalized tutoring sessions help you zero in on your weakest areas—whether it's sterile-processing audits or post-market surveillance—so you walk into the exam room fully prepared.

• Submit Your Application

  • Online submissions are reviewed within 1-2 business days.

  • Paper applications take 3-5 business days for initial review.

• ASQ Evaluation

  • Once ASQ completes its review, you'll receive an approval email or a “hold” notice requesting additional information.

  • If you don't meet the eligibility criteria, ASQ will refund your fee minus a $130 processing charge.

• Testing Formats

  • Computer-Based Testing (CBT):
    Within 1-2 business days of approval, you'll get an eligibility email with scheduling instructions for Prometric.

  • Paper-Based Testing (PBT):
    For paper-based or translated exams, you won't receive an eligibility email. Instead, you'll get a seating letter—detailing your exam date, time, and location—about two weeks before the test.

• Schedule Your Exam
  Book your appointment with Prometric during the testing window you selected when applying.