Our team of Human Factors Engineers and certified Ergonomists has extensive experience in applied Human Factors Engineering / Usability Engineering (HFE/UE) processes for medical R&D. We can conduct a single usability test or manage the entire Usability Engineering process for your system or device. Utilizing our experience with product design and development, we can support the integration of HFE/UE into your product development process and work with your team to identify practical solutions to usability challenges, including physical ergonomics and cognitive UI. Our experts can also help you respond quickly when a critical human-factors-related deficiency is identified in a regulatory submission.
- Generative User Research
- In-house Usability Test Suite
- Usability Engineering File Development (IEC 62366 compliance)
- Task Analysis
- Expert/Heuristic Analysis
- Formative User Evaluation Studies
- Use-related Risk Analysis (UFMEA, URRA, etc.)
- IFU / Labeling Validation
- Summative Usability Validation Testing
- HFE Reports for FDA Submissions
- Responding to FDA Deficiency Reports