ASQ Certified Medical Device Auditor (CMDA) Exam Preparation Course

Duration: ~91 Hours | 89 Modules

The Alpha TC ASQ Certified Medical Device Auditor (CMDA) Exam Preparation Course is an exam-focused training program aligned to the ASQ CMDA Body of Knowledge (BoK). The course prepares participants to successfully sit for the ASQ CMDA certification examination and to competently perform ISO 13485 Quality Management System audits within medical device and regulated environments.

The course combines auditing fundamentals with a clause-by-clause review of ISO 13485, emphasizing regulatory intent, objective evidence, risk-based thinking, and audit effectiveness.

Course Structure

• Lecture and instructional content: ~52 hours

• Quizzes, knowledge checks, and practice exams: ~19 hours

• Directed reading and study: ~20 hours

• Total expected course time: ~91 hours

Course Content (ASQ BoK Aligned)

• Auditing principles, ethics, and auditor responsibilities

• Audit planning, interviewing, sampling, and evidence collection

• Writing audit findings and nonconformities

• ISO 13485 requirements and regulatory intent

• Risk management and process effectiveness

• Corrective action, CAPA, and continual improvement

• CMDA exam format and test-taking strategies

Learning Outcomes

Participants will be able to:

• Interpret and apply the ASQ CMDA Body of Knowledge

• Plan and conduct ISO 13485 audits

• Evaluate compliance and effectiveness of medical device QMSs

• Write clear, value-added audit findings

• Confidently sit for the ASQ CMDA certification exam

Course Materials Included

• CMDA Instructor Notes

• ASQ CMDA Handbook

• ASQ-approved calculator

• Two-year online access to lectures, quizzes, and practice exams

• Shipping costs included for physical materials

Target Audience

Medical device auditors, quality professionals, regulatory professionals, engineers, and individuals seeking ASQ CMDA certification.