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Exam Review

Key Facts: CMDA Exam

150

Exam Questions

ASQ

$418/$568

Exam Fee (Member/Non)

ASQ

4.5 hrs

Time Limit

ASQ

Open Book

Exam Format

ASQ

The CMDA is ASQ's specialized certification for auditors in the medical device industry. It validates competence in auditing against ISO 13485, FDA 21 CFR Part 820, and other regulatory frameworks governing medical devices. CMDA holders conduct internal, supplier, and third-party audits to ensure medical device manufacturers maintain compliant quality management systems.

Sample CMDA Practice Questions

Try these sample questions to review concepts for the CMDA exam. Each question includes a detailed explanation. Start the interactive quiz above for the full 125+ question experience with AI tutoring.

1Under FDA 21 CFR 820, which document contains the complete set of records for a specific production unit of a medical device?
A.Device History Record (DHR)
B.Device Master Record (DMR)
C.Technical File
D.Design History File (DHF)
Explanation: The Device History Record (DHR) contains the production records for each specific unit or lot of a finished medical device, including dates of manufacture, quantities, acceptance records, and labeling. The DHF documents the design process, the DMR defines the finished device specifications, and the Technical File is an EU regulatory submission. Exam tip: Remember DHR = 'History of what was actually made' vs. DMR = 'Recipe for making it.'
2Which regulatory framework replaced the Medical Device Directives (MDD) in the European Union?
A.CE Marking Directive 93/42/EEC
B.EU IVDR 2017/746
C.ISO 13485:2016
D.EU MDR 2017/745
Explanation: EU MDR 2017/745 (Medical Device Regulation) replaced the MDD (93/42/EEC) and became fully applicable on May 26, 2021, with extended transition periods for certain devices. It introduced stricter requirements for clinical evidence, post-market surveillance, and Unique Device Identification. The IVDR covers in vitro diagnostics specifically, and ISO 13485 is a quality management standard, not a regulation. Exam tip: Know the key date — MDR fully applied May 26, 2021.
3What is the primary purpose of ISO 13485:2016 in the medical device industry?
A.To specify requirements for a quality management system for medical device organizations
B.To define clinical investigation protocols
C.To establish biocompatibility testing standards
D.To classify medical devices by risk level
Explanation: ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It is harmonized with many regulatory frameworks worldwide. Device classification is handled by regulations like the EU MDR, biocompatibility by ISO 10993, and clinical investigations by ISO 14155. Exam tip: ISO 13485 is the QMS standard — it is NOT a product standard.
4Which countries participate in the Medical Device Single Audit Program (MDSAP)?
A.USA, Canada, Brazil, Japan, and Australia
B.USA, Canada, UK, Germany, and France
C.USA, EU, Japan, China, and South Korea
D.USA, EU, Canada, India, and Mexico
Explanation: MDSAP allows a single regulatory audit of a medical device manufacturer's quality management system to satisfy the requirements of five regulatory jurisdictions: the United States (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (MHLW/PMDA), and Australia (TGA). This reduces the audit burden on manufacturers who sell in multiple markets. Exam tip: Remember the five MDSAP countries — US, CA, BR, JP, AU — the EU is notably NOT a participant.
5According to FDA 21 CFR 820, what must a manufacturer establish and maintain to ensure purchased or otherwise received product and services conform to specified requirements?
A.Purchasing controls
B.Incoming inspection waivers
C.Vendor scorecards
D.Supplier corrective action requests
Explanation: FDA 21 CFR 820.50 requires manufacturers to establish and maintain procedures to ensure that purchased or otherwise received product and services conform to specified requirements. This includes evaluation of suppliers, contractors, and consultants, as well as maintaining purchasing data that clearly describe the specified requirements. Vendor scorecards and CARs may be part of the process but are not the regulatory requirement itself. Exam tip: 820.50 Purchasing Controls is a frequent audit focus — know the three elements: evaluation, purchasing data, and acceptance.
6Under the EU MDR, what is the maximum validity period for a CE certificate issued by a Notified Body?
A.5 years
B.10 years
C.7 years
D.3 years
Explanation: Under EU MDR 2017/745 Article 56(1), certificates issued by Notified Bodies have a maximum validity of five years from the date of issue and may be renewed upon application for further periods of up to five years each. This is consistent with the MDD but now includes more rigorous surveillance audit requirements. Exam tip: MDR certificates = max 5 years, and Notified Bodies must conduct at least one unannounced audit per manufacturer within the certificate period.
7Which FDA regulation requires medical device manufacturers to report deaths, serious injuries, and certain malfunctions to the FDA?
A.21 CFR 814 — Premarket Approval
B.21 CFR 820 — Quality System Regulation
C.21 CFR 803 — Medical Device Reporting
D.21 CFR 860 — Medical Device Classification
Explanation: 21 CFR Part 803 (Medical Device Reporting or MDR) establishes the requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events to the FDA. Manufacturers must report deaths and serious injuries within 30 calendar days and must submit 5-day reports for events requiring remedial action. Exam tip: Do not confuse MDR (Medical Device Reporting, 21 CFR 803) with EU MDR (Medical Device Regulation 2017/745) — same acronym, very different things.
8Under ISO 13485:2016, when is design and development validation required to be performed?
A.Prior to transfer to manufacturing, under defined operating conditions
B.Only when requested by the customer
C.Only after regulatory submission
D.After the first commercial shipment
Explanation: ISO 13485:2016 clause 7.3.6 requires that design and development validation be performed prior to the transfer of the medical device to production, under defined operating conditions representing the intended use. Validation confirms the resulting product meets the needs of the user and intended uses. Exam tip: Verification = 'Did we build it right?' (meets specifications). Validation = 'Did we build the right thing?' (meets user needs).
9What classification rule under the EU MDR generally applies to non-invasive medical devices that come into contact with injured skin and are intended to be used as a mechanical barrier for compression or absorption of exudates?
A.Class I
B.Class IIb
C.Class IIa
D.Class III
Explanation: Under EU MDR Annex VIII Rule 4, non-invasive devices that come into contact with injured skin and are used as a mechanical barrier, for compression, or for absorption of exudates are generally classified as Class I. However, if the device is intended for wounds that breach the dermis and can only heal by secondary intent, it may be classified higher. Exam tip: EU MDR classification rules (Annex VIII) use 22 rules — know the general principles and which device types escalate in class.
10Under MDSAP, which regulatory authority's requirements dictate the grading of nonconformities as either 'major' or 'minor'?
A.The MDSAP Regulatory Authority Council defines a single universal grading system
B.Grading is optional and left to auditor discretion
C.Each participating regulatory authority grades independently based on its own regulations
D.Only FDA grades apply across all jurisdictions
Explanation: MDSAP uses a single unified nonconformity grading system based on the GHTF/IMDRF Nonconformity Grading System (MDSAP AU P0037), not independent major/minor grading by each authority. Auditors assign point grades using a standardized matrix against ISO 13485:2016 requirements, then apply escalation rules. This harmonized approach supports information exchange among participating regulatory authorities. Exam tip: MDSAP replaced traditional major/minor labels with a 1–5 point grading system — know the GHTF grading matrix and escalation rules.

About the CMDA Exam

The CMDA certification from ASQ validates expertise in auditing medical device quality management systems, including ISO 13485, FDA QSR, and regulatory compliance.

Exam sponsor: ASQ. The requirements and fees below concern the certification or admission exam, separate from our free practice resources.

Questions

150 questions

Time Limit

4.5 hours

Passing Score

Pass/Fail (scaled)

Exam / Certification Fees

$418/$568

Exam sponsor website

Fees, eligibility, and exam policies can change. Confirm them with the exam sponsor before applying or paying.

Our practice resources: topics covered

We aim to reflect publicly available exam outlines and topic information in our study resources. Coverage, format, and difficulty may differ from the actual exam, and we cannot guarantee that every detail is accurate or current. Confirm exam requirements, fees, and policies with the official exam sponsor.

25%

Regulatory Framework

FDA QSR (21 CFR 820), EU MDR, ISO 13485, and global medical device regulatory requirements

25%

Medical Device Quality Systems

Design controls, production controls, CAPA, risk management (ISO 14971), and complaint handling

30%

Audit Process

Audit planning, execution, evidence evaluation, nonconformity classification, and reporting

20%

Product Realization & Lifecycle

Design and development, purchasing controls, process validation, and post-market surveillance

Preparing for the CMDA Exam

What You Need to Know

  • Passing score: Pass/Fail (scaled)
  • Exam length: 150 questions
  • Time limit: 4.5 hours
  • Exam / certification fees: $418/$568 Official sources

Using Our Practice Resources

  • Work through all 125 available questions
  • Review every answer and explanation
  • Track weak areas and revisit them
  • Use our AI tutor for tough concepts

CMDA: Suggested Study Strategy

1Focus on Audit Process (30%) — master audit planning, execution, evidence collection, and nonconformity writing
2Study ISO 13485 clause by clause and understand how it differs from ISO 9001 for medical devices
3Know FDA 21 CFR Part 820 Quality System Regulation and its design control requirements
4Review risk management per ISO 14971 including hazard analysis, risk estimation, and risk control
5Understand EU MDR requirements for technical documentation, clinical evaluation, and post-market surveillance

Frequently Asked Questions

What is the CMDA exam?

The CMDA (Certified Medical Device Auditor) is ASQ's certification for professionals who audit medical device quality management systems. It covers ISO 13485, FDA QSR, EU MDR, audit methodology, and medical device regulatory compliance.

How many questions are on the CMDA exam?

The CMDA exam has 150 multiple-choice questions to be completed in 4.5 hours. The exam is open-book and administered at Pearson VUE testing centers worldwide.

What is the CMDA passing score?

The CMDA uses a scaled scoring system with a Pass/Fail result. ASQ does not publish the exact cut score. The exam tests both auditing methodology and medical device regulatory knowledge.

What experience is needed for the CMDA?

CMDA candidates need 8 years of experience in medical device quality or auditing. A degree offsets some experience: a bachelor's counts as 4 years, a master's as 5 years. At least 3 years must involve medical device auditing activities.

What is the difference between CMDA and CQA?

The CMDA is specifically designed for medical device auditing, covering ISO 13485, FDA QSR, and EU MDR regulations. The CQA (Certified Quality Auditor) is a general audit certification applicable across all industries without medical device-specific regulatory content.