Which document captures evidence of risk management activities for a medical device?

• A. Design History File
• B. Technical File
• C. Risk Management File
• D. Post-Market Surveillance Report

Answer: (C)

A medical device’s risk management activities are documented in the Risk Management File. This file serves as the central record of all risk-related work, including the risk management plan, hazard analyses, risk assessments, chosen risk controls, and evaluations of residual risk. It shows how risk controls were implemented, verified, and re-evaluated as new information becomes available, ensuring traceability from initial hazards to accepted risk levels and regulatory compliance (e.g., ISO 14971).

Other documents focus on related areas but not the ongoing record of risk activities: a Design History File tracks design processes and changes, a Technical File compiles regulatory information about the device, and a Post-Market Surveillance Report documents monitoring and safety signals after launch.