Usability Engineering File (UEF)

A Usability Engineering File (UEF) actively compiles a comprehensive set of documents that record every aspect of the usability engineering process for medical devices. It thoroughly details user research, risk assessments, usability evaluations, and design validation activities. The UEF not only provides essential evidence of regulatory compliance but also ensures the device consistently meets usability standards and requirements.

At Human Factors Design Consulting, we can thoroughly assess your product’s current design and documentation for  UEF compliance. If any components are missing to meet FDA and 62366-1 requirements, we will promptly identify them. Moreover, we offer a clear roadmap to help you complete any remaining requirements.

Inspecting the UEF according to IEC 62366-1 ensures compliance. The UEF plays a crucial role in the design process by providing a structured approach to guaranteeing the safety and effectiveness of medical devices. By thoroughly documenting user research, risk assessments, and validation studies, the UEF actively supports regulatory compliance. Moreover, organizing your human factors design effort through a well-prepared UEF is not only the most effective strategy but also a requirement by the FDA.