Free CMDA sample questions
Real questions from the ASQ Certified Medical Device Auditor practice bank, with the correct answer and an explanation for each one. No junk, no filler.
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Showing 6 of 12 free sample questions.
While conducting a third-party audit of a contract manufacturer, the lead auditor encounters a highly specialized laser-welding technique. A technical expert is brought in to assist. Which TWO of the following accurately describe the technical expert's boundaries and responsibilities? (Select TWO)
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?
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?
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?
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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