Guidance on applying human factors to medical devices

This guidance is primarily aimed at manufacturers of medical devices and UK Approved Bodies responsible for assuring their quality. It clarifies that usability engineering is an iterative process, involving design, testing, and validation stages. The process requires attention to post-market phases, where evidence may come to light that the design needs further improvement. A usability engineering process can help identify and mitigate patient and user safety risks, and improve device design through analysis of incidents.