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  1. Programs
  2. Medical Device Auditor (CMDA)

Medical Device Auditor (CMDA)

American Society for Quality (ASQ)

Certification

Become a contributor for free to openly demonstrate student outcomes, industry alignment & eligibility criteria.

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.

Cost

Exam Fee $550 Retakes $350Show moreShow less

Format

Hybrid

Eligibility Calculator

Which aid programs apply to this program?

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Program Pathways

Credentials this program stacks toward

No program pathways.

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Program Details

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.

Requirements

What you need to earn this credential

No requirements listed.

Financial Aid

Eligible funding programs

No funding information available.

Scholarships

No scholarships listed.

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Locations

Where this program is offered

No locations specified.

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Related Programs

Programs related to this one

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Skills & Competencies

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
Career Pathways

Occupations this program prepares you for

  • Medical Equipment Preparers31-9093.00
What You'll Learn

Key competencies developed through this program

Auto-populated·from NSX Competency Framework

Mastery: developing (Level 2)(based on Certification)

  • Steam autoclave loads and maintenance logs — operate equipment and maintain complete records of cycles, load contents, and routine maintenance in a central sterile unit with minimal oversight.
  • Multi-step instrument cleaning and decontamination workflows — perform routinely and efficiently across a variety of instrument types in a busy surgical services department.
  • Sterilizer biological and chemical indicator tests — conduct, interpret, and document results independently according to facility policy and accreditation standards.
  • Specialty surgical instrument trays and custom supply kits — organize and assemble accurately by referencing specialty preference cards in a sterile processing department.
  • Medical equipment and devices — examine systematically for wear, loose parts, and functional defects during scheduled inspection rounds in a clinical support area.
  • Inventory levels for medical instruments and supplies — monitor usage trends and initiate reorder requests through inventory management software before stock reaches critical levels.
  • Crash carts and emergency supply stations — restock and document completeness after each use in compliance with facility protocols and regulatory requirements.
  • Equipment deficiency reports — communicate clearly to supervisors and clinical staff using established incident reporting channels and electronic messaging systems.
  • Scheduling and workload prioritization tools — use calendar and time-accounting software to manage daily assignments and meet surgical case start times.
  • Sterilization and processing quality standards — apply critical thinking to identify non-conforming loads and escalate appropriately within a hospital sterile processing department.

Some details on this page are auto-populated from public workforce data sources: O*NET (opens in new tab), BLS (opens in new tab), College Scorecard (opens in new tab), DOL Training Provider Results (opens in new tab), NSX (opens in new tab). Provided in partnership with LER.me Career Intelligence.

Student Outcomes

Performance metrics for this program

Completion Rate
Not reported
Placement Rate
Not reported