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!

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