In the context of ISO 14971, the first step in developing a risk management plan for a medical device is risk analysis. Risk analysis involves identifying hazards associated with the medical device and estimating the potential risks they pose. This process includes determining the severity and probability of harm that may occur due to each identified hazard.
Beginning with risk analysis allows manufacturers to understand the possible dangers their device could present and lays the groundwork for subsequent steps in risk management, such as risk evaluation, risk control, and continuous monitoring. By thoroughly analyzing risks first, manufacturers can prioritize their risk control efforts to effectively mitigate those that pose the greatest threat to patient safety.
In contrast, other steps like risk estimation or risk control come after the initial analysis phase. Risk estimation specifically occurs after hazards have been identified, where the likelihood and consequences of potential occurrences are quantified. Risk control involves mitigating the identified risks, which cannot be effectively planned without first understanding what those risks are through thorough analysis. Therefore, starting with risk analysis is essential for a structured and comprehensive approach to risk management in medical device development.