Since our inception in 2001, we've worked exclusively with pharmaceutical and medical device clients providing HUMAN FACTORS EXPERTISE at every step of the development and regulatory process.
We have only ever worked in the medical space.
We understand the challenges unique to medical product design.
HF is all we do. 24/7/365.
Let us do the heavy lifting for you.
We have been doing this for over 20 years and take great pride in not only understanding FDA expectations but helping develop usable products.
We look at your program as more than a checkbox. This is our specialty!
Our TECHNICAL DIRECTORS have an average of 20 years experience as human factors professionals supporting medical product design teams. We've helped our clients through the regulatory approval process, including aiding with successful 510(k), PMA, NDA, BLA, and ANDA applications.
FORMATIVE AND VALIDATION STUDIES