Which sequence correctly describes ISO 14971 risk management steps for a rehabilitation device?

• A. Identify hazards, estimate risk, and release the product.
• B. Define device features, perform marketing analysis, and launch.
• C. Identify hazards, assign risk corresponding severity and probability, estimate risk, implement controls, reevaluate residual risk, and produce a Risk Management File.
• D. Conduct a clinical trial to assess safety before any risk assessment.

Answer: (C)

ISO 14971 frames risk management for medical devices as an iterative process that begins with identifying hazards and ends with documenting the decisions and results in a formal file. The sequence in the correct option reflects that flow: you start by identifying hazards, then estimate risk by combining how severe the potential harm could be with how likely it is to occur, then implement controls aimed at reducing that risk. After applying those controls, you reevaluate the remaining or residual risk to see if it’s acceptable, and you compile all this into the Risk Management File, which serves as the official record of the risk management process and its outcomes. This documentation is essential for demonstrating compliance and traceability.

The other options miss or misorder steps: one focuses on marketing and release rather than risk control and documentation; another centers on defining features and launching without performing a structured risk assessment; and another suggests conducting a clinical trial before any risk assessment, which contradicts the idea that risk management guides testing and product decisions.