Medical Device Human Factors

User Research & Testing ​ [HF]

Ensure your medical devices are examined from every angle

When you need to ensure that your medical device is performing at the highest standards, objective human factors analysis is vital. Exponent assists medical device manufacturers in developing and navigating regulatory roadmaps — from proof of concept, through development, to premarket regulatory submissions, to post-market safety and efficacy management.

Medical device design and user interaction testing.

Medical device design challenges include technological complexity, interactivity with associated devices and services, and compliance with FDA and EU medical device industry regulations. Manufacturers and developers must integrate safety, anthropometrics, and different user environments into their product lifecycles to mitigate use-related hazards and risks.

Exponent's medical device support is a unique offering, combining scientific disciplines of human factors with mechanical and biomedical engineering to provide bespoke product support — from registration, to regulatory compliance, to post-market activities.

At our 6,000 square foot, multiuse Centers for Scientific User Research (CSUR) lab, we conduct simulated use tests, user group evaluations on intended populations, and use-related hazards analysis in risk management for a wide range of medical devices and components. We also offer documentation and labeling, and post-market surveillance support.

Download our medical device human factors brochure to learn more.

Our Capabilities Are Unparalleled

With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.


Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.