Successful Human Factors Programs: Key Considerations from a Regulator's Perspective
By Melissa R. Lemke -
Published 12 December 2017
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.
Categories: Features, US, FDA, Medical Devices, Research and development
Tags: Human Factors Engineering, HFE, Guidance
Medical Device Regulatory Update: Usability, UDI and RoHS
By Lori A. DonDiego, MBA, RAC -
Published 23 September 2014
Human factors engineering (HFE), unique device identifiers (UDIs) and restriction of hazardous substances (RoHS) have more in common than one might think. At the recent 2014 RAPS San Francisco Bay Area Chapter’s annual educational conference, attendees gathered to enhance their understanding of HFE, the requirements for UDI and the impact of the RoHS 2 Directive 2011/65/EU1 aimed at devices currently under Directive 93/42/EEC (MDD) and 90/385/EEC (IVD).
Categories: Features, Europe, US, Compliance, Drugs, In vitro diagnostics, Manufacturing, Medical Devices, Packaging
Tags: Human Factors Engineering, HFE, usability engineering, Unique Device Identifiers, UDI, medical electronics, RoHS, restriction of hazardous substances, FDA, EU, directives