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Shep Bentley

Principal Consultant, Bentley Biomedical Consulting, LLC

Shep Bentley is the President and Principal Consultant for Bentley Biomedical Consulting, LLC, where he is responsible for regulatory strategies leading to FDA approvals and clearances for digital medical device companies. Shep began his career in 1984 at the Hospital Corporation of America as a research technician, and worked at McGaw Labs in Irvine, responsible for GMPs until 1989, when he joined TOSHIBA America where he managed production of various digital devices. He founded Rising Star, a contract manufacturer for digital medical assemblies in 1993, and sold it in 1997 to Standard Industries in Anaheim. He was a founder of Volcano Therapeutics, Inc. in 2001, which was acquired by Philips in 2015.

For the past fourteen years since 2004 as an independent consultant, Shep has worked to achieve device approvals and clearances from the FDA, and market entry for numerous innovative medical technologies and applications within the European Union, Canada, Brazil and across Asia. He speaks regularly at regulatory conferences, has just co-authored a book on device approval and provides independent consulting for clients of Intertek.

He is a graduate of The University of The South, and has studied international literature at the Johannes Gutenberg University in Mainz, Germany. He is a member of AAMI, ASQ, RAPS, TOPRA and on the Program Committee of the Orange County Regulatory Affairs (OCRA) Discussion Group. He has been a featured speaker on the topic of cybersecurity for the past two years at the FDA Annual Meeting, and the Medtech Monday events in California.

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