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Regulations & Standards Compliance


UserWise consultants have experience assuring compliance to the following regulations, standards, and guidances as they relate to the usability engineering process. We actively participate in the development of human factors standards through participation on the AAMI Human Factors Engineering Committee and the International Standards Committee (IEC 62A Joint Working Group 4).

Regulations
  • 21 CFR Part 820.30 (c), (d), & (f)
  • EU Medical Device Regulation (2017/745)
Standards
  • IEC 62366-1:2015 & IEC62366:2007/A1 (2014) 
  • ISO 14971:2007, 2012, & 2019
  • IEC 60601-1-6
Guidances
  • FDA: Applying Human Factors and Usability Engineering to Medical Devices
  • FDA: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (DRAFT)
  • FDA: List of Highest Priority Devices for Human Factors Review (DRAFT)
  • MHRA: Human Factors and Usability Engineering - Guidance for Medical Devices Including Drug-device Combination Products
And More!

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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