Certified Medical Device Auditor (CMDA)

Certified Medical Device Auditor (CMDA) 

The Certified Medical Device Auditor (CMDA) credential is a respected professional certification offered by the American Society for Quality (ASQ). It’s designed for quality and compliance professionals who want to show solid expertise in auditing medical device quality systems against international standards, regulatory requirements, and industry best practices.

Target Audience

This credential is ideal for professionals working in or aspiring toward roles such as:

• Medical Device Quality Assurance Specialist
• Regulatory Affairs Professional
• Lead Auditor or Internal Auditor in the medical device sector
• Supplier Quality Engineer
• Quality Systems Auditor or Consultant

Eligibility Requirements

To sit for the CMDA exam, candidates must have:

• At least five years of relevant, full-time work experience in one or more areas covered by the CMDA Body of Knowledge.
• At least one of those five years must be in a decision-making role — meaning you had authority to plan work, control processes, or make key decisions.

Education can reduce the required work experience:

• Associate degree = 1 year waived
• Bachelor’s degree = 3 years waived
• Master’s or doctorate = 4 years waived

Skills Required for CMDA Certification

• Medical device audit planning, execution, and follow-up
• Understanding of ISO 13485 and FDA QSR requirements
• Ability to identify nonconformities, risks, and compliance gaps
• Root cause analysis and CAPA evaluation skills
• Process-based and risk-based auditing approach
• Strong documentation review and evidence-gathering skills
• Clear audit reporting and professional communication
• Ethical judgment, independence, and confidentiality

Course Outline

The Certified Medical Device Auditor (CMDA) exam covers the following topics - 

• Domain 1. Auditing Fundamentals
• Domain 2. Audit Planning and Preparation
• Domain 3. Conducting the Audit
• Domain 4. Audit Reporting and Follow-Up
• Domain 5. Medical Device Quality Management Systems
• Domain 6. Product Realization and Lifecycle Controls
• Domain 7. Measurement, Analysis, and Improvement
• Domain 8. Regulatory and Standards Requirements
• Domain 9. Risk Management
• Domain 10. Statistical and Analytical Tools
• Domain 11. Professional Ethics and Auditor Conduct