RAC Post-Market Surveillance 4

Question 1

Under ISO 13485:2016, which clause specifically requires procedures for post-market surveillance activities including feedback and complaint handling?

Accepted Answer

Clause 8.2 — Monitoring and Measurement

Answer

ISO 13485:2016 Clause 8.2 covers monitoring and measurement, including customer feedback, complaint handling, and reporting to regulatory authorities.

Question 2

A PMS plan should define data sources, evaluation methods, and thresholds for action. Which element is MOST critical for triggering a CAPA?

Accepted Answer

Pre-defined signal detection thresholds based on risk

Answer

Pre-defined, risk-based signal thresholds ensure that PMS data triggers corrective action objectively, before problems escalate.

Question 3

Which FDA guidance describes the expectation that manufacturers maintain a vigilance system to detect, report, and correct problems with marketed devices?

Accepted Answer

FDA Guidance on Medical Device Reporting for Manufacturers

Answer

FDA's MDR guidance for manufacturers outlines the vigilance system expectations, including what constitutes a reportable event and required timelines.

Question 4

When conducting trend analysis on PMS data, which statistical approach is typically used to identify a statistically significant increase in adverse event rates?

Accepted Answer

Control charts (SPC) comparing current rates to historical baseline

Answer

Statistical Process Control charts allow manufacturers to detect signals that exceed normal variation, objectively flagging when rates have moved beyond expected limits.

Question 5

Which of the following scenarios represents a 'near miss' that should still be captured in the PMS system even though no injury occurred?

Accepted Answer

A device alarmed incorrectly but the clinician caught the error before patient harm

Answer

Near-miss events where device performance could have caused harm are valuable PMS data because they signal potential failure modes requiring risk assessment.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Post-Market Surveillance 4