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Expertise

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. 

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!
"We had a great experience with UserWise. Our regulatory submission was well-received and a win; we obtained the outcome we hoped for. Perhaps most telling is the fact that we're back for more; we've just launched our second project with UserWise."

Jen Marler, MD | Sr. Director Clinical & Medical Affairs | Carrot Inc.

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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