Friday, 9 November 2018
6:00-8:00 pm CDT
Emergo by UL Headquarters
2500 Bee Cave Road
Building One, Conference Room B120
Austin, TX 78746
+1 512 327 9997
Come engage with professionals from your local regulatory community for an interactive presentation on the important role that human factors engineering plays in the submission of medical devices. FDA’s human factors engineering (HFE) guidance, issued in its final form in February 2016, as well as IEC 62366-1:2015, describe substantial expectations for how medical device developers should apply HFE. These high expectations apply to new products and, in some cases, existing (i.e., legacy) devices.
During this talk, UL’s Andrea Dwyer, managing human factors specialist and co-author of the book Medical Device Use Error – Root Cause Analysis, will provide a general introduction to HFE practices aligned with today’s regulatory landscape. The presentation will include tips on effective strategies to fulfill both FDA’s expectations and those established by the IEC standard, which is upheld by many other regulators. Following this presentation, we will have an interactive question and answer period.
This event is coordinated by the RAPS Texas chapter and is intended to encourage knowledge sharing and community development among local regulatory professionals. A light meal will be provided and RAC holders may claim two RAC recertification credits.
Andrea Dwyer, MS, CHFP, managing human factors specialist, UL-Wiklund
RAPS Members: $25