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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)

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