Craig Nichols

Craig has nearly 10 years of experience in the medical device industry, having served in a variety of roles. He spent 5 years at the FDA as a lead reviewer in the Division of Cardiovascular Devices, leading diverse teams of experts and reviewing over 150 FDA submissions for Class II and III medical devices. Throughout his time at the FDA, he developed expertise in reviewing technical engineering documentation, quality system design and management, pre-clinical and clinical testing design for product development, GLP regulations, and medical device manufacturing.

Following his time at FDA, Craig was a Fellow in Stanford’s Biodesign Innovation Program, where he learned a proven, repeatable process to identify important healthcare needs, invent novel health technologies to address them, and prepare to implement those products into patient care through start-up, corporate channels, or other channels. Craig and his team evaluated a number of unmet needs during the Biodesign program, including one need that led to the founding of Emme, for which Craig provided initial regulatory strategy.

He holds a B.S. in Applied Science/Biomedical Engineering from the University of North Carolina at Chapel Hill.