Successful Human Factors Programs: Key Considerations from a Regulator's Perspective

Posted 12 December 2017 By Melissa R. Lemke

placeholder+image This article provides two regulatory leaders insight on human factors engineering considerations for helping manufacturers optimize user interfaces and successfully meet regulatory expectations to bring safe, effective and usable medical devices to market. It was developed from an interview with Shannon Hoste, team lead of the Center for Devices and Radiological Health's (CDRH's) human factors premarket evaluation team and Michael Ryan, acting deputy director in the division of anesthesiology, general hospital, respiratory, infection control, and dental devices.

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Categories: Medical Devices, Research and development, Features, US, FDA

Tags: Human Factors Engineering, HFE, Guidance

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