Medical Device Auditor (CMDA)
American Society for Quality (ASQ)
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.
Duration
Not specified
Credits
Not specified
Cost
Exam Fee $550 Retakes $350
Format
Hybrid
What You'll Learn
AI-generatedKey competencies developed through this program
- KnowledgeAnalyze medical device quality management systems using regulatory standards and audit frameworks to identify compliance gaps.Developing
- KnowledgeApply standards, regulations, directives, and guidance documents to medical device audit scenarios across different organizational contexts.Developing
- KnowledgeEvaluate adequacies and deficiencies in medical device quality systems using systematic examination and questioning techniques.Developing
- KnowledgeExamine process safety management and control elements within medical device manufacturing and quality assurance environments.Developing
- KnowledgePrepare comprehensive audit reports documenting system compliance following professional auditing standards and best practices.Developing
- KnowledgeDemonstrate audit planning and execution methodologies using various audit tools and techniques in medical device settings.Developing
- KnowledgeInterpret regulatory requirements and quality system criteria to assess adherence in medical device organizations.Developing
- MindsetEngage with auditees and stakeholders using professional questioning techniques while maintaining objectivity and integrity.Developing
- MindsetRespect ethical principles and confidentiality requirements when conducting audits and handling sensitive organizational information.Developing
- KnowledgeCompare observed practices against established medical device standards to determine conformance and identify opportunities for improvement.Developing
Skills developed through this program
- Interpret audit types, roles, and professional requirements in the context of ethical, legal, and regulatory expectations for auditing
- Apply medical‑device quality management system requirements in environments governed by U.S. and international regulations and standards
- Use quality tools to analyze processes and support decision‑making within medical‑device quality systems
- Apply risk‑management and sterilization standards to assess hazard detection and compliance for aseptic and terminally sterilized products
- Evaluate risk‑management programs and compliance processes when assessing complaint handling, vigilance, MDR, tracking, recall procedures, and validation activities
- Interpret biocompatibility standards and testing rationale to evaluate environmental controls and determine qualification, validation, or maintenance needs for facility utilities
Occupations this program prepares you for
Detailed information about this program
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.
What you need to earn this credential
No requirements listed.
Eligible funding programs
No funding information available.
Scholarships
No scholarships listed.