How can robust risk management support post-market surveillance for a rehabilitation device?

• A. It eliminates the need for post-market actions
• B. It identifies potential hazards, informs training and labeling updates, and guides monitoring and corrective actions after market release
• C. It only applies during design and has no post-market relevance
• D. It guarantees zero adverse events

Answer: (B)

Robust risk management is a living process that informs post-market surveillance by continually identifying hazards and evaluating remaining risk as real-world data come in. After a device is released, new or evolving use cases, patient populations, and field conditions can reveal hazards or change the severity and likelihood of risks. The risk management process uses this information to update the risk assessment, implement or adjust risk controls, and determine what needs to be communicated through training and labeling. This ongoing cycle also guides how monitoring should be conducted, what signals to watch for in PMS, and when corrective actions or improvements are needed. In short, it provides the framework and evidence base for ongoing monitoring, learning, and action after the device is on the market, helping keep risk at an acceptable level.

The other statements don’t fit because risk management does not eliminate post-market actions, and it is not limited to the design phase or to a guarantee of zero adverse events. Post-market actions remain essential, and risk management supports, guides, and updates them rather than removing their need.