# Audit checklist for the U.S. Food and Drug Administration (FDA)'s Guidance
# document "Applying Human Factors and Usability Engineering to Medical Devices"
# Based on version 2011-06-21
#
# This checklist is not a substitute for reading, understanding, and
# implementing the associated guidance document, which can be found online for
# free on https://www.fda.gov. The descriptive phrase following each keyword
# reference is intended only as a helpful mnemonic for locating
# and recalling the referenced section of the standard.
#
FDA-HFE:4.1 Include user interaction hazards in risk analysis
FDA-HFE:4.2.a Process for identifying use-related hazards
FDA-HFE:4.2.b Process for mitigating use-related hazards
FDA-HFE:4.2.c Process for human factors validation testing
FDA-HFE:5.1 Document device users
FDA-HFE:5.2 Document device use environment
FDA-HFE:5.3 Document device user interface
FDA-HFE:6.1 Categorize user tasks by on severity of potential harm
# TODO: add remaining items; this is a WIP
