The Usability Engineering Report (UER) documents how a manufacturer has ensured their device can be used safely and effectively by its intended users.
The UER template provides manufacturers with a framework for documenting usability engineering activities in accordance with Regulation (EU) 2017/745 Annex I, IEC 62366-1, IEC/TR 62366-2, and ISO 14971. It captures how use-related hazards and risk scenarios were identified, how those risks were analysed and controlled, and how the user interface was validated through formative and summative evaluations. And where a user interface has limited prior validation history, the template supports the justification of evaluation activities (UOUP approach), ensuring manufacturers can demonstrate compliance in complex validation scenarios.
By bringing all usability evidence together in one traceable document, it demonstrates to regulators that user interaction has been systematically considered at every stage of device development.
This template is built by experienced regulatory professionals who understand what regulators expect from usability engineering documentation.
Price: $500
