Managing use-related risks is central to IEC 62366 Application of usability engineering to medical devices and FDA’s guidance on Applying Human Factors and Usability Engineering to Medical Devices.
A Use-Related Risk Analysis is a helpful tool in applying ISO 14971 risk management principles to use of a medical device. Specifically, this technique allows stakeholders to identify use-related hazards and hazardous situations, estimate & evaluate the risks, and document control measures implemented to mitigate risk.
A Use-Related Risk Analysis is typically drafted as the medical device design and workflow begin to take shape, and it is continually updated as the design evolves and new information is collected during development. Content in the risk analysis is challenged during formative studies, summative (use validation) testing, and on-market surveillance phase.
