In March 2010, IEC 62366:2007, “Medical Devices–Application
of Usability Engineering to Medical Devices,” went into effect, and compliance
to this standard is now required by the European regulatory bodies. Compliance
to the standard’s predecessor, ANSI/AAMI HE74:2001, “Human Factors Design
Process for Medical Devices,” has been required by the FDA for more than ten
years. Both documents state that medical device manufacturers must demonstrate
that all potential use-related hazards in their devices have been identified,
tested, and mitigated.
Differentiating Between Validation Testing and Other Usability Testing
November 8, 2011 by
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