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Expertise You Can Trust


At UserWise, our human factors consultants have worked on a vast variety of medical devices and combination products spanning numerous medical disciplines, use environments, and user groups. From crafting relevant justifications to creating an accurate model of the use environment for the summative testing, our experienced team can lead you through the entire usability engineering process. Our consultants will develop a customized usability engineering plan for your specific medical device based on the user, use environment, target submission, and complexity of your medical product. We regularly work with all relevant human factors standards, regulations and guidances including those required for CE Mark, FDA approval, and electrical safety testing. Contact us today to learn how UserWise consultants can help you navigate the human factors requirements for your medical product. 

About Us


Our consultants partner with medical device companies to fulfill any and all steps of the Usability Engineering Process.

UserWise offers a wide range of services spanning the product development cycle. Our consultants assist in performing user research, constructing the use-related risk analysis, conducting formative evaluations, executing summative usability validation testing, refining user manuals, compiling the Usability Engineering File and FDA Human Factors/Usability Engineering Submission Report, and so much more. 

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