OTC Webinar: ABCs of Medical Device Development

Join Elaine Duncan, President of Paladin Medical, as she discusses the basics of design documentation for medical devices and how to document 1) unmet needs, 2) translate those needs into specification and 3) how to think about and draft an early hazard analysis and risk assessment.

Bio:

Elaine Duncan, MS.ME., RAC, FAIMBE, is the founder and president of Paladin Medical, Inc. Elaine is a certified regulatory affairs professional with a master’s degree in engineering (mechanical/biomedical). Elaine holds an appointment as an Adjunct Professor of Biomedical Engineering in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering at the University of Kentucky.