Risk Management is a systematic approach to identifying, analyzing, evaluating, controlling, and monitoring all kinds of risks associated with a medical device from its design stage to the end of life. This is exactly what all of the above represents throughout the Risk Management as ISO 14971 requires. The management has to provide evidence of its commitment to the risk management process, ensuring the provision of adequate resources and assigning qualified personnel for risk management.
This Risk management module is designed to meet the demands for risk-driven design in medical devices. It can be used either integrated into the Traceability Matrix to address each requirement or as a stand-alone module to help you address more general concerns. Its purpose is to help you document controls that were likely included in the requirement, that by design, controlled a hazard. Design decisions can now be linked to how hazards were mitigated before they became hazards.