What is the function of a risk management plan according to ISO 14971?

The function of a risk management plan according to ISO 14971 is to document the systematic approach for managing risks associated with medical devices. ISO 14971 provides a framework for identifying, assessing, controlling, and monitoring risks throughout the life cycle of a medical device. This involves a detailed process that includes risk analysis, risk evaluation, and risk control measures to ensure that any potential hazards associated with the device are understood and adequately mitigated.

By requiring documentation of this systematic approach, the risk management plan ensures that all stakeholders, including manufacturers and regulatory bodies, have a clear understanding of how risks are being managed. It also serves as a crucial tool for compliance with regulatory requirements, as it provides evidence that the manufacturer has thoughtfully considered and addressed the risks associated with their device.

This focus on systematic risk management, rather than attempting to eliminate all risks, aligns with the understanding that some level of risk may be acceptable depending on the benefits provided by the medical device.