CERTIFIED MEDICAL DEVICE AUDITOR CMDA

WHY BECOME A
CERTIFIED MEDICAL DEVICE AUDITOR?
As a Certified Medical Device Auditor (CMDA) you will be 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 adequacies
and deficiencies. A CMDA analyzes all elements of the system and reports on how well it adheres to the
criteria for management and control of process safety.

What Are the Core Competencies of a CMDA?

• Comprehend different types of audits, audit roles • Evaluate risk management programs and requirements
and responsibilities, and the ethical, legal, and for complaint handling, vigilance, medical device
professional issues associated with audits. reporting (MDR), and tracking and product recall
processes. Review validation procedures for laboratory
• Apply and understand a broad variety of medical
testing and use appropriate methods for analyzing,
device quality management system requirements
detecting, and controlling nonconformances.
including U.S. and foreign regulatory laws and
regulations (e.g., Code of Federal Regulations, • Identify and describe biocompatibility terms and test
21 CFR 820) and international standards for selection rationale in accordance with applicable
quality (e.g., ISO 9001, ISO 13485). standards and guidelines. Evaluate environmental
controls and determine whether utilities require
• Understand quality tools such as Pareto charts, cause
qualification, validation, or maintenance.
and effect diagrams, flowcharts, statistical process
control (SPC) charts, check sheets, scatter diagrams, • Recognize the elements of the software development
histograms, and plan-do-check-act (PDCA). life cycle for products, processes, and quality systems.

• Identify and apply standards related to risk manage-

ment, hazard detection, and sterilization for aseptically
processed and terminally sterilized products.

What Is the Value to Your Company? What Is the Value to You?

• Ensure conformity to industry standards and • An improved skill set qualifies you for more positions
compliance with regulations and requirements within modern business environments.
regarding quality systems, complaints, MDRs,
• CMDAs with a job title of auditor make an average
product classification, and more.
of $96,827 per year, compared to auditors without
• Understand industry auditing tools like FDA certification, who make approximately $73,975.*
Quality System Inspection Technique (QSIT)
and risk-based auditing.
*Please see the current Quality Progress Salary Survey at:
• Mitigate expensive risks using appropriate asq.org/qualityprogress/ under Tools and Resources.
sterilization methods and processes.

• Improve processes by implementing quality

tools and techniques.
CERTIFIED MEDICAL DEVICE AUDITOR CMDA
Qualifications and Medical Device Auditor Learning
Requirements for CMDA Certification Resources and Certification Preparation
Candidates must have five years of full-time work • Biomedical Auditor Exam Preparation Class
experience in one or more areas of the CMDA
• The Biomedical Quality Auditor Handbook, Third Edition
Body of Knowledge, including one year in a
decision-making position. • Medical Device Division—an ASQ professional network

Education Recertification Required?

Candidates who have completed a degree from a Yes, every three years.
college, university, or technical school can waive
some part of the five-year experience requirement as
follows (only one of these waivers may be claimed): How to Enroll for Certification
• Associate’s degree—one year waived Visit asq.org/cert
• Bachelor’s degree—three years waived

• Master’s or doctorate degree—

four years waived

MARKETPLACE INFORMATION
COMMON JOB FUNCTIONS COMMON INDUSTRIES
Medical Device Auditor Cardiovascular Devices
Medical Device Engineer Consulting and/or Third-Party Auditing
Project Manager General Hospital Devices
Quality Audit Manager Implants and Prosthetic Devices
Quality Engineer In Vitro and Diagnostic Devices
Quality Manager Manufacturing Equipment/Medical Device
Regulatory Expert Medical Device
Regulatory Manager Pharmaceutical
Supplier Quality Engineer Surgery and Life Support Devices

Key Markets
• Risk management (ISO 14971)

• Risk-based decision making

• FDA 21 CFR 820 compliance

• ISO 13485