Certification

Medical Device Auditor (CMDA)

American Society for Quality (ASQ)

Median earnings
Cost
$550
Duration
Completion

The Certified Medical Device Auditor 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 adequacies 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.

hybridProgram details →

Skills taught

Interpret audit types, roles, and professional requirements in the context of ethical, legal, and regulatory expectations for auditingApply medical‑device quality management system requirements in environments governed by U.S. and international regulations and standardsUse quality tools to analyze processes and support decision‑making within medical‑device quality systemsApply risk‑management and sterilization standards to assess hazard detection and compliance for aseptic and terminally sterilized productsEvaluate risk‑management programs and compliance processes when assessing complaint handling, vigilance, MDR, tracking, recall procedures, and validation activitiesInterpret biocompatibility standards and testing rationale to evaluate environmental controls and determine qualification, validation, or maintenance needs for facility utilitiesRecognize software development life‑cycle elements to assess product, process, and quality‑system software requirements
← Browse credential pathways