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Exam Information
Official specifications published by ASQ
Exam Format
258 min
145
550/750
Professional
Registration
Prometric or online proctoring
English
Validity
3 years
Earn 18 Recertification Units (RUs) through professional development activities; Retake and pass the current CMDA examination
CMDA Exam Topics and Domains
CMDA is organized into 5 weighted domains.
1
Auditing Fundamentals
8.89%
Types of Audits
Audits by purposeAudits by methodData privacy
- Identify and distinguish between audits by purpose: organizational effectiveness, system efficiency, business performance, process effectiveness, risk management, regulatory compliance, supplier qualification, compliance with standards, design history file compliance, and for-cause audit
- Identify and distinguish between audits by method: product, process, system, first-party, second-party, third-party, internal, external, desk, management, department, and function
- Demonstrate the importance of maintaining confidentiality of personal information reviewed during audits
Audit Roles and Responsibilities
Key functions and responsibilities of audit participants
Explain key functions and responsibilities of various audit participants including audit team members, lead auditor, client, auditee, etc.
Ethical, Legal, and Professional Issues
Professional conduct and responsibilitiesLegal consequences and liability
- Define and apply the ASQ Code of Ethics, concepts of due diligence and due care with respect to confidentiality and conflict of interest
- Identify potential legal and financial ramifications of improper auditor actions in various situations
2
Auditing and Inspection Processes
20.74%
Audit Preparation and Planning
Elements of the audit planning processAuditor selectionAudit-related documentationAuditing toolsAuditing strategiesLogistics
- Determine and implement steps in audit preparation and planning
- Identify and examine various auditor selection criteria and effectiveness characteristics
- Identify sources of pre-audit information and examine audit-related documentation
- Select and prepare working papers including checklists and log sheets
- Identify and use various tactical methods for conducting an audit
- Identify and organize various audit-related logistics
Audit Performance
Opening meetingData collection and analysisData integrity principlesCommunication techniquesOrganization and analysis of objective evidenceOn-site audit managementExit/closing meeting
- Manage the opening meeting of an audit
- Select and apply various data collection methods and evaluate results
- Examine record-keeping requirements and evaluate data for ALCOA compliance
- Define and apply appropriate interviewing and communication techniques
- Identify, differentiate, and classify sources of objective evidence
- Interpret situations throughout audit performance and manage changes
- Formally manage exit/closing meetings
Audit Report
Basic elementsEffective audit reportsRecord retention
- Define, plan, and apply the steps in generating an audit report
- Report observations and nonconformances accurately with objective evidence
- Identify and apply record retention requirements
Audit Follow-Up and Closure
Elements of corrective and preventive action (CAPA)Review of corrective action planConducting audit follow-upAudit closure
- Identify and apply the elements of CAPA processes including root cause analysis
- Use various criteria to evaluate corrective action plan acceptability
- Use various methods to verify and evaluate effectiveness of corrective actions
- Identify and apply various elements of and criteria for audit closure
Audit Procedural References
International guidelines for auditing quality systemsQuality System Inspection Technique (QSIT) and FDA CPG 7382.845
- Understand general auditing principles as described in ISO 19011 and the MDSAP audit model
- Understand QSIT auditing requirements and explain the purpose and scope of FDA CPG 7382.845
3
Medical Device Quality Management System Requirements
28.15%
Regulatory Laws and Requirements
FDA - Code of Federal Regulations (CFR) Title 21U.S. requirements (FD&C Act)EU MDR 2017/745Health CanadaOther international agencies
- Identify, define, and apply FDA CFR Title 21 Parts relevant to medical devices
- Identify how the FD&C Act defines and differentiates between device classifications and pre-market requirements
- Recognize requirements of the EU MDR 2017/745 and key differences with U.S. regulations
- Recognize current Health Canada requirements and key differences with U.S. regulations
- Recognize requirements enforced by international agencies such as TGA and PMDA
Requirements for In Vitro Diagnostic (IVD) Devices
IVD regulatory requirements
Recognize the requirements of 21 CFR 809 and IVDR 2017/746 as they apply to in vitro diagnostic devices
International Standards for Quality Systems
Quality system standards selection and use
Evaluate the selection and use of ISO 9001, ISO 13485, and ISO 17025 quality system standards
Quality System Regulation (QSR) Requirements (21 CFR 820)
Management responsibility (Parts 20, 22, 25)Design controls (Part 30)Document (Part 40) and record control (Parts 180-186)Purchasing controls and acceptance activities (Parts 50, 80, 86)Identification and traceability (Parts 60, 65)Production and process controls (Parts 70, 75)Inspection, measuring, and test equipment (Part 72)Nonconforming product (Part 90)Corrective and preventive action (CAPA) system (Part 100)Product handling, storage, distribution, and installation (Parts 140-170)Complaint files (Part 198)Servicing (Part 200)Statistical techniques (Part 250)
- Assess management responsibility for the quality system
- Evaluate scope, purpose, and implementation of design controls
- Describe and review document and change control system elements
- Describe supplier qualification and purchasing control requirements
- Use appropriate methods for identification and traceability
- Assess production and process controls including process validation
- Determine suitability and calibration of inspection equipment
- Determine adequacy of nonconforming product procedures
- Assess CAPA system and evaluate its effectiveness
- Determine adequacy of handling, storage, distribution, and installation procedures
- Determine adequacy of complaint handling and servicing procedures
- Determine adequacy of statistical techniques and sampling plans
Post-Market Surveillance
Post-market surveillance activities
- Determine the appropriateness of post-market surveillance procedures
- Define and describe vigilance, MDR, and AER requirements
- Review adequacy of product recall, corrections, removals, and tracking requirements
4
Technical Medical Device Knowledge
31.11%
Risk Management
ISO 14971IEC 62366ISO 13485 risk-based controls
- Describe principles of risk management per ISO 14971
- Determine suitability of hazard identification processes per IEC 62366
- Describe and assess risk-based controls for QMS processes per ISO 13485
Design Control
Human factors and usability engineeringBiological evaluationPackagingDevice shelf lifeGeneral safety and performance requirements
- Evaluate human factors and usability studies performed during design and development
- Describe material characterization and biocompatibility test selection rationale
- Interpret packaging standards for sterile and non-sterile products
- Explain device shelf life determination
- Identify elements of GSPR per EU MDR 2017/745
Software Development and Maintenance for Products
Product software lifecycle
- Identify principles of product software lifecycle in accordance with FDA guidance and IEC 62304
- Describe the software development lifecycle model including V&V, cybersecurity, change control, and risk management
Labeling
Labeling requirements
- Identify labeling requirements for devices per 21 CFR 801
- Understand the use of symbols per ISO 15223 and UDI per 21 CFR 830
Controlled Environments and Utility Systems
Controlled environmentsUtility systems
- Identify and interpret controlled environment specifications per ISO 14644
- Review housekeeping, disinfection, and sanitization processes
- Describe utility system setups and their qualification/validation requirements
Sterile Medical Devices
DefinitionsMethodsProcess controls and validation for EtO and radiation
- Describe and distinguish between aseptically processed and terminally sterilized products
- Identify basic elements of sterilization methods
- Determine appropriate validation and process controls for EtO and radiation sterilization per ISO 11135 and ISO 11137
Laboratory Testing and Failure Analysis
Laboratory test methods
Assess procedures and records used for laboratory test methods and determine their appropriateness
Validation
Validation types and elements
Define and evaluate elements of different types of validations including process, cleanliness, test method, and rework
Reprocessing/Reuse and Cleaning of Medical Devices
Reprocessing and cleaning validations
Identify elements of reprocessing and cleaning validations in accordance with FDA guidance
Common Medical Device Directives and Standards
IEC 60601-1Restriction of Hazardous Substances (RoHS) directiveREACH
Define and describe elements of IEC 60601-1, RoHS, and REACH as they relate to medical devices
Sources for New and Evolving Standards
Standards and guidance document sources
Describe sources for standards and guidance documents including FDA Recognized Consensus Standards Database, Harmonised Standards, MEDDEV, NBOG, and Europa
5
Quality Tools and Techniques
11.11%
Quality Control and Problem-Solving Tools
Seven basic quality tools and problem-solving tools
Identify, interpret, analyze, and draw conclusions based upon quality control and problem-solving tools
Process Improvement Techniques
Process capabilitySix SigmaLean toolsMeasurement system analysis (MSA)Cost of quality (COQ)
- Identify and interpret various process capability indices
- Identify and define the Six Sigma DMAIC phases
- Identify and define various lean tools
- Identify and define MSA terms and their effects on measurement systems
- Define and describe the four basic cost of quality categories
Data Types and Sampling
Qualitative and quantitative analysisAttributes and variables dataSampling
- Describe qualitative and quantitative data analysis and determine if problems are systemic or isolated
- Determine appropriate use of attributes vs variables sampling plans
- Identify and interpret sampling plans and determine their statistical validity
How do I earn this certification?
Passing CMDA earns the Certified Medical Device Auditor (CMDA) certification. It sits in the Auditing / Medical Device Quality track.
Next Level Options
CMQ/OE - ASQ Certified Manager of Quality / Organizational ExcellenceAdvances to quality management leadership role with broader organizational impact
Alternative Paths
- CFSQA - ASQ Certified Food Safety and Quality AuditorSimilar auditing skillset applied to food safety and quality systems (for career diversification)
- CCQM - ASQ Certified Construction Quality ManagerApplies quality management skills to construction industry
Practice with Precision
The PlanetCert Simulator mirrors the real exam environment with authentic questions and timed pressure.
How to study for this exam?
The most effective way to prepare for CMDA is by using the PlanetCert Simulator to practice questions and review detailed explanations.
What's changed on this exam?
Current Status
ACTIVE
Updates
- FDA QMSR (Quality Management System Regulation) Effective February 2, 2026 Direct impact on Domain III - the QMSR replaces the traditional QSR by incorporating ISO 13485:2016 by reference. Candidates must understand both the historical QSR framework and the new QMSR alignment. FDA now has authority to inspect management review and supplier audit records. Compliance Program 7382.850 replaces 7382.845. • Release date: 2026-02-02
- EU MDR 2017/745 Full Implementation Fully applicable The EU MDR is fully applicable and continues to be tested in Domain III. Auditors must understand GSPR requirements, device classification under EU MDR, and the differences from U.S. regulations. • Release date: 2021-05-26
- IVDR 2017/746 Fully applicable The In Vitro Diagnostic Regulation is tested in Domain III Topic B. Auditors must understand IVD-specific requirements separate from general device regulations. • Release date: 2022-05-26
- Medical Device Cybersecurity Evolving FDA guidance Cybersecurity considerations are part of Domain IV Topic C (Software Development). The growing emphasis on cybersecurity in medical devices makes this an increasingly important area for auditors.
Who should take this exam?
5 years of on-the-job experience in one or more areas of the CMDA Body of Knowledge
1 year of experience must be in a decision-making position
- Experience in medical device quality systems
- Familiarity with FDA regulations and ISO standards
- Prior auditing experience