CMDA Practice Questions
Prepare for CMDA with more than an answer.
- Level
- Professional
- Valid for
- 3 years
Domains covered on the exam 5
- Auditing Fundamentals8.89%
- Auditing and Inspection Processes20.74%
- Medical Device Quality Management System Requirements28.15%
- Technical Medical Device Knowledge31.11%
- Quality Tools and Techniques11.11%
- 1
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: B
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.
- 2
Upon finalizing the audit report for a complex Class III device manufacturer, the lead auditor notes a systemic failure in the design transfer process. To maximize the impact and clarity of this finding for executive management, how should the nonconformance be presented in the report?
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Correct answer: C
An effective audit report utilizes an executive summary to highlight critical, systemic risks for top management, while prioritizing data and citing exact objective evidence in the main body to facilitate corrective action.
- 3
Six months after issuing a major nonconformance regarding inadequate supplier evaluation, the auditor returns to verify the effectiveness of the CAPA. The auditee presents a newly revised SOP for supplier qualification. What additional evidence is absolutely necessary for the auditor to verify the effectiveness of this corrective action?
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Correct answer: B
To verify CAPA effectiveness, an auditor must see objective evidence that the new process (the revised SOP) actually works in practice over time, which requires reviewing completed records generated by the new process.
- 4
Under the FDA's Quality System Inspection Technique (QSIT), if an investigator is conducting a 'Level 2' (Comprehensive) inspection, which subsystems are mandatory to cover?
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Correct answer: B
A comprehensive (Level 2) QSIT inspection mandates the coverage of all four major subsystems: Management Controls, Design Controls, CAPA, and Production and Process Controls.
- 5
During an annual review, the quality assurance director tasks a compliance specialist with verifying that the newly implemented automated assembly line meets all documented operational parameters and yields. What type of audit is specifically being requested?
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Correct answer: B
A process audit examines an activity or operation against specific instructions or standards to ensure it is operating within established limits, such as verifying the parameters and yields of an automated assembly line.
- 6
True or False: According to the ASQ Code of Ethics, if an auditor discovers a critical safety defect that management refuses to address, their duty of confidentiality strictly prohibits them from notifying external regulatory bodies under any circumstances.
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Correct answer: B
The ASQ Code of Ethics mandates that professionals hold paramount the safety, health, and welfare of the public. If management refuses to act on a critical safety defect, the duty to public safety supersedes the duty of confidentiality to the employer or client.
