"Our company recently engaged Clinical Evidence Solutions to conduct comprehensive human factors testing for one of our Class II medical devices as part of our FDA submission preparation. From the initial consultation through protocol development, participant recruitment, moderated usability sessions, formative/summative testing, and final reporting, their team demonstrated deep expertise, professionalism, and a thorough understanding of FDA's Applying Human Factors and Usability Engineering to Medical Devices guidance (and related standards such as IEC 62366 and ISO 14971).

Thanks to their work, we identified and addressed several important use-related risks early, which ultimately strengthened our device's safety profile and accelerated our path toward clearance.

I would not hesitate to partner with Clinical Evidence Solutions LLC again and enthusiastically recommend them to any medical device company seeking reliable, high-quality human factors and usability support. They are true professionals who combine scientific rigor with practical business acumen..

Senior Director, Product & Compliance