Human Factors. Regulatory Compliance. One Integrated Program.
Usability is not a UX exercise. It is a safety and regulatory requirement.
IEC 62366-1 mandates a documented usability engineering process for virtually every target market. Yet most manufacturers treat it as a late-stage checkbox — resulting in use errors that trigger recalls, summative tests that fail at submission, and Usability Engineering Files that collapse under notified body scrutiny.
A structured program from intended use to approved Usability Engineering File.
We integrate usability engineering into your design process from the start, so every user study, every risk analysis, and every document is built on a defensible foundation.
Usability Engineering Planning
We define your intended users, use environments, and use scenarios — then build a Usability Engineering Plan that is fully integrated with your risk management process from day one.
Formative & Summative Testing
We design and execute user studies at every design stage: formative sessions to drive iterative improvement, and a final summative evaluation to demonstrate safe use for your regulatory submission.
Usability Engineering File
We compile the complete IEC 62366-1-compliant Usability Engineering File — including use-related risk analysis, user interface specifications, and all study documentation — ready for notified body review.
Your Complete Usability Engineering File
A fully documented IEC 62366-1 program, ready to submit and ready to defend.
- Usability Engineering Plan (IEC 62366-1 compliant)
- Intended use, user profile, and use environment definitions
- Task analysis and use error analysis
- Formative evaluation reports with design recommendations
- Summative evaluation protocol and final report
- Complete Usability Engineering File (UEF) for submission
A summative test failure at submission costs you the entire submission cycle. A UEF that collapses under review costs you more.
By integrating usability engineering from the start of design, we prevent use errors from becoming safety risks, ensure your summative test passes on the first attempt, and deliver a UEF that withstands the most demanding notified body review.
Speak with a Usability Engineering Specialist TodayFrequently Asked Questions
Common questions about medical device usability engineering.