Human Factors Engineering to Satisfy the New IEC 62366-1, -2
October 10, 2018 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:416-915-4438\58
IEC has released a new medical device usability standard, IEC 62366-1:2015, “Usability Engineering in IEC 62366-1:2015 — Part 1: Application of the new Usability Engineering Standard to Medical Devices” and “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Its 9 Stages provide a repeatable process for performing UE and documenting the process and results in a UE File. These address an on-going concern by regulatory agencies in both the US and EU, human factors engineering, or it’s synonym, usability engineering.
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