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"The UserWise team was very responsive to feedback from the company and helped us to quickly address any questions from FDA that came up regarding human factors with satisfactory results."

Lisa Claude, CCRA | RAC Sr. Director of Clinical & Regulatory

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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UserWise, LLC
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