Factoring In Human Factors: An Interview With Peter Carstensen
This article was originally published in The Gray Sheet
Executive SummaryHuman factors engineering has slowly but surely become an ingrained part of how FDA regulates the medical device industry, according to Peter "Pete" Carstensen, but to keep that a reality he says the agency needs to hire more people and reestablish its former human factors-focused team
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FDA identified the device types that almost always need human factors, or usability, data included in premarket submissions in a draft guidance posted in conjunction with final guidelines with broader human factors testing recommendations.