- Pang-Jen KungJanuary 14, 20232250June 30, 2026June 30, 2027
Pang-Jen Kung
The Certified Medical Device Auditor (CMDA) is a professional who understands the principles of standards, regulations, directives, and guidance for auditing a medical device system while using various tools and techniques to examine, question, evaluate, and report on that system’s adequacy and deficiencies. A medical device auditor analyzes all elements of the system and reports on how well it adheres to the criteria for management and control of process safety
Each certification candidate is required to pass an examination that consists of multiple-choice questions that measure comprehension of the Body of Knowledge.
Skills / Knowledge
- Medical Device Auditing
- Quality Auditing
- Auditing Fundamentals
- Audit Process
- Audit Preparation
- Audit Planning
- Audit Reporting
- Corrective and Preventive Action
- Quality Management System Requirements
- Regulatory Laws and Requirements
- Quality System Regulation
- Risk Management
- Quality Tools
- Technical Medical Device Knowledge
Issued on
January 14, 2023
Expires on
June 30, 2027