BlackHägen Design’s Human Factors Engineers possess vast expertise in applying their understanding of human behavior, abilities, limitations, and the impact of user interface design on interactions with technology. This knowledge integrates with Human Factors Engineering/Usability Engineering (HFE/UE) to develop outstanding products collaboratively. We excel in tailoring the HFE/UE process to meet our clients’ anticipated and unforeseen needs. Our services encompass comprehensive support, starting from early user and design research (Contextual Inquiry) to generating essential documentation for Design Controls. Additionally, we adopt a collaborative solution-oriented approach with Design Engineers, ensuring equitable use-related risk control measures and conducting end-phase Summative Usability Evaluations. We provide the necessary reporting for successful Regulatory submissions.
- 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