About
The Certified Medical Device Auditor (CMDA®) certification validates expertise in auditing medical device quality management systems. Certified professionals demonstrate a comprehensive understanding of industry standards, regulations, and auditing methodologies to assess and ensure compliance. Earning this certification showcases commitment to quality and process improvement within the medical device sector.
Certification Body: American Society for Quality (ASQ®)
Learning Objective
- Understand medical device quality management system requirements.
- Learn auditing fundamentals, techniques, and best practices.
- Gain expertise in regulatory compliance, directives, and industry standards.
- Develop skills to analyze, evaluate, and report on process efficiency and safety.
- Enhance decision-making capabilities in audit-related roles.
Exam Information
The CMDA examination assesses comprehension of the Certified Medical Device Auditor Body of Knowledge (BoK) through multiple-choice questions.
Exam Format:
- Computer-Based Test (CBT): 145 multiple-choice questions (135 scored, 10 unscored). Total exam duration: 4.5 hours.
- Paper-Based Test: 135 multiple-choice questions. Total exam duration: 4 hours.
- Language: English.
- Exam Type: Open book (reference materials permitted).
- Result Notification: CBT results available immediately; official confirmation within 3-5 business days.
- Re-exam Policy: Candidates can reapply within two years at a reduced rate.
Recertification
- Required every three years.
- Maintain via professional development or exam retake.
- Ensures expertise in auditing & evolving regulations.
Eligibility
- Experience: Five years of full-time, paid experience in medical device auditing or related fields.
- Decision-Making Role: At least one year must be in a role with authority over project execution, process control, or outcomes.
- Education Waivers:
- Associate’s Degree: 1 year waived
- Bachelor’s Degree: 3 years waived
- Master’s/Doctorate: 4 years waived
Target Audience
- Medical device quality auditors and compliance professionals.
- Regulatory affairs specialists.
- Quality assurance managers and consultants.
- Healthcare professionals involved in medical device compliance.
- Professionals seeking career advancement in the medical device industry.
Curriculum
The CMDA certification program covers critical areas of medical device auditing, including:
- Auditing Fundamentals – Principles, ethics, and methodologies.
- Auditing and Inspection Processes – Planning, execution, and reporting.
- Medical Device Quality Management System Requirements – Compliance with industry standards.
- Technical Medical Device Knowledge – Product classifications, risk management, and regulatory frameworks.
- Quality Tools and Techniques – Root cause analysis, corrective actions, and process improvements.
For more details, visit ASQ’s official website and begin your journey toward becoming a Certified Medical Device Auditor.
