Pulse Check: New Revision for ISO 62366-1 Application of Usability Engineering to Medical Devices
Michelle's Moment: Last month, I had attended a "Meet the Experts" event sponsored by UL. The day was very informative with presentations by their experts on human factors engineering (HFE), 60601-amendment update, risk management, and material characterization. One topic of particular interest covered the recent changes to ISO 62366-1 Application of Usability Engineering to Medical Devices which was updated in March. Somehow amid the myriad of other regulatory changes this year, this one managed to slip by me! For others who may have missed the revision, here are some highlights:
One outcome of the revision resulted in better alignment with terminology the FDA HFE guidance.
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