What are the key components of risk management in medical device development?

The key components of risk management in medical device development focus primarily on strategies to ensure patient safety and device effectiveness. The correct choice emphasizes the essential steps of identifying, evaluating, and controlling risks associated with the device.

Identifying risks involves recognizing potential hazards that could affect the safety and performance of the medical device, including possible failure modes, user errors, and environmental factors. Evaluating risks assesses the likelihood and severity of these identified risks, helping to prioritize which risks need active management. Controlling risks then involves implementing strategies to mitigate these risks, which may include design changes, labeling adjustments, and other controls to ensure that the overall risk remains acceptable.

This comprehensive approach is fundamental in complying with regulatory requirements and ensuring that devices are safe for their intended use. Other options focus on processes that, while important in the broader scope of medical device development, do not specifically address the systematic methodology of risk management that is critical in ensuring patient safety and compliance with regulations.