The FDA issued a draft guidance document on ‘Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety & Effectiveness in Design’ for Industry and FDA Staff as of June 22, 2011. A 90 day comment period is
ANSI/AAMI HE75:2009 — Human f…
ANSI/AAMI HE75:2009 — Human factors engineering – Design of medical devices http://ow.ly/1hMzF