CMDA Sample Questions & Answers
Technical device knowledge like risk management and design control carries the top share, just ahead of quality management system regulations, preparing, performing and reporting on audits, basic quality tools, and foundational auditor roles.
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- Question 1Intermediate
Auditing Fundamentals · Types of Audits
While reviewing complaint files during a routine surveillance audit, an external auditor notices that patient medical records, including unredacted names and treatment histories, are attached to the investigation forms. What is the optimal immediate action the auditor should take?
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Correct answer: C
Auditors must maintain data privacy. Viewing unredacted patient data (PHI) is a privacy violation. The auditor must stop, notify management of the issue, and request properly redacted documents (de-identified data) to continue evaluating the complaint handling process.
- Question 2Intermediate
Auditing and Inspection Processes · Audit Preparation and Planning
Prior to initiating a supplier qualification audit for a new critical component vendor in Germany, the lead auditor is finalizing the audit plan. Given the limited two-day on-site window, which tactical auditing strategy is best suited to efficiently verify the traceability of raw materials from the finished goods backward?
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Correct answer: B
Backward tracing is the tactical strategy of starting with a finished output (e.g., a released component) and tracing its history backward through production records to the original raw material inputs, effectively verifying traceability.
- Question 3Beginner
Auditing and Inspection Processes · Audit Preparation and Planning
When assembling a team for an internal QMS audit, the audit program manager must select individuals based on specific criteria. Which of the following characteristics is most critical for ensuring the objectivity of the audit process?
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Correct answer: B
A fundamental principle of auditing (ISO 19011) is independence. To remain objective, auditors must not audit their own work or have direct responsibility for the areas they are auditing.
- Question 4Advanced
Auditing and Inspection Processes · Audit Performance
A multinational medical device manufacturer recently transitioned to a fully electronic Quality Management System (eQMS). During an FDA inspection, the investigator focuses on the data integrity of the environmental monitoring records in the ISO Class 7 cleanroom. The facility uses automated particle counters that transmit data wirelessly to a central server. The investigator discovers that while the system logs the time and date of particle counts, the generic login 'Cleanroom_Tech' is used by all operators on the shift to acknowledge alarms. Furthermore, the system allows supervisors to overwrite alarm acknowledgment comments without retaining the original text. The firm argues that the raw particle count data cannot be altered, thus ensuring data integrity. Evaluate the scenario based on ALCOA principles. Which specific ALCOA elements are primarily violated by the current system configuration?
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Correct answer: A
Using a generic login violates 'Attributable' because it is impossible to know WHICH specific technician acknowledged the alarm. Allowing supervisors to overwrite comments without an audit trail retaining the first entry violates 'Original' (and accurate), as the true original record is destroyed.
flowchart TD A[Data Generation] --> B{ALCOA Check} B -->|Attributable| C[Who? - FAILED: Generic Login] B -->|Legible| D[Readable? - PASS] B -->|Contemporaneous| E[When? - PASS] B -->|Original| F[Source? - FAILED: Overwritten] B -->|Accurate| G[Correct?] - Question 5IntermediateSelect 2
Auditing and Inspection Processes · Audit Performance
During a QSIT-based audit of the Production and Process Controls subsystem, the auditor is evaluating the environmental controls of a facility manufacturing sterile implants. Which TWO methods of objective evidence collection would yield the most reliable verification of continuous compliance? (Select TWO)
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Correct answers: D, E
Documentary evidence of continuous automated monitoring provides highly reliable, historical, objective proof that environmental parameters were maintained over time.
Direct observation provides immediate, factual objective evidence of whether personnel are actually adhering to established environmental control procedures in practice.
- Question 6Beginner
Auditing and Inspection Processes · Audit Performance
The lead auditor is conducting the opening meeting for a recertification audit to ISO 13485:2016. Which of the following elements MUST be established and communicated to the auditee's management during this meeting?
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Correct answer: A
Standard audit procedure (ISO 19011) dictates that the opening meeting must confirm the audit plan, including the scope, criteria (e.g., ISO 13485), and how findings will be classified and reported.
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