Medical Devices Part 1: Application of Usability Engineering to Medical Devices
This document specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors
engineering) process permits the manufacturer to assess and mitigates risks associated with
correct use and use errors, i.e., normal use. It can be used to identify but does not assess or
mitigate risks associated with abnormal use.
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