Description

The Usability File Template, as per the guidelines of IEC 62366, provides a structured framework for documenting the usability engineering process for medical devices. It encompasses the planning, execution, and reporting of usability activities aimed at ensuring that the device is safe and effective for its intended users and use environments. The template includes sections for user research, task analysis, use-related hazards, usability specifications, and validation testing results. By utilizing the Usability File Template, medical device manufacturers can demonstrate compliance with usability engineering requirements and enhance the usability and user experience of their devices.