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Compliance Corner: FDA Investigator Lists 7 Common Human Factors Problems, Says Usability Is 'Overlooked'

Executive Summary

Longtime agency investigator Laureen Geniusz reveals seven usability issues that agency investigators regularly see when inspecting medical device manufacturing facilities – troubles that could jeopardize patient safety. Her chief concern? "Human factors seems to be overlooked and not fully understood," Geniusz says.


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