PhD-led usability research, validation testing, and regulatory documentation for medical device manufacturers. From first prototype to final submission, we get it right.
Build an FDA-ready human factors program from day one. IEC 62366 compliance, submission strategy, and HFE/UE report development.
Find usability problems before they become redesign costs. Iterative studies from early prototypes through design lock.
Prove your device is safe to use with data FDA accepts. Simulated-use studies, knowledge tasks, and validation documentation.
Connect your risk management to real user behavior. uFMEA methodology integrated with ISO 14971 design controls.
Know what your users actually need before you build it. Strategic VoC research for market viability and unmet needs.
Get a clear picture of where your HFE program stands. Low-commitment entry point to identify gaps and build a plan.
Two PhD human factors scientists with complementary specializations in behavioral psychology and biomedical engineering.
Every client who followed our recommendations received FDA clearance. Across 510(k), PMA, and De Novo pathways.
Consumer tech rigor from Google, Sony, and Intuit meets FDA regulatory expertise. Your users deserve both.
3 to 4 concurrent programs without enterprise overhead or 6-month contract minimums. Faster turnaround, competitive pricing.