What is the CMDA Certification?

The Certified Medical Device Auditor (CMDA) is a professional certification offered by the American Society for Quality (ASQ) that validates expertise in auditing medical device quality systems and knowledge of related regulations.

This credential demonstrates to employers and clients that you possess specialized knowledge and skills in medical device auditing, which is a critical function for ensuring product safety, regulatory compliance, and quality in the highly regulated medical device industry.

The CMDA Body of Knowledge

The certification exam is based on the CMDA Body of Knowledge, which covers six main domains:

1. Quality System Fundamentals:
   • FDA Quality System Regulation
   • ISO 13485 requirements
   • Risk management principles
   • International regulations
2. Auditing Fundamentals:
   • Audit preparation and planning
   • Audit performance techniques
   • Documentation and reporting
   • Corrective action verification
3. Regulatory Authority Inspections:
   • FDA inspections
   • EU notified body audits
   • International regulations
4. Management and Personnel:
   • Management responsibility
   • Personnel competence
   • Organization structure
5. Product and Process Design Controls:
   • Design and development
   • Validation and verification
   • Risk management
6. Production and Process Controls:
   • Process validation
   • Monitoring and measurement
   • Process improvement

Eligibility Requirements

To be eligible for the CMDA certification, you must meet the following requirements:

• A minimum of five years of on-the-job experience in one or more of the areas of the CMDA Body of Knowledge
• Education can substitute for some experience:
  • An associate degree = 1 year of experience
  • A bachelor's degree = 2 years of experience
  • A master's or doctorate degree = 3 years of experience
• The experience must be in a decision-making position

Recertification

CMDA certification is valid for three years. To maintain your certification, you must either:

• Retake and pass the CMDA exam, or
• Earn 18 recertification units (RUs) from activities such as:
  • Employment in the field
  • Membership in professional organizations
  • Continuing education
  • Courses taught
  • Publishing articles or books
  • Participation in committee work