According to ISO 14971, what is the first step when developing a risk management plan for a device?

The first step when developing a risk management plan according to ISO 14971 is risk analysis. This is crucial because risk analysis involves the identification of potential hazards associated with the medical device, the estimation of the severity and probability of harm, and the evaluation of the risks. Identifying and understanding these risks is a foundational aspect of effective risk management.

After the risks have been analyzed, the subsequent steps can involve risk estimation, risk control, and overall risk management processes, but they are contingent upon the insights gained in the risk analysis phase. This initial step ensures that the risk management plan is based on a comprehensive understanding of the risks involved, enabling informed decisions on how to address and mitigate those risks effectively throughout the lifecycle of the medical device.