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Regulations & Standards Compliance


UserWise human factors consultants work with our clients to assure compliance to the following regulations, standards, and guidances as they relate to the usability engineering process.

IEC 62366-1:2015
IEC 62366:2007 / A1 (2014) ISO 14971:2007 & 2012
IEC 60601-1-6

FDA CDRH Guidance: Applying Human Factors Usability to Medical Devices (2016) as well as draft Guidances by CDRH and CDER

MHRA Guidance: Human Factors and Usability Engineering-Guidance for Medical Devices Including Drug-device Combination Products 

21 CFR Part 820.30 (c), (d), and (f)

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
Office Hours
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