Overview of US Class III PMA Device Regulatory Pathway

OCRA-CRQST Speaker Series

FDA medical device regulatory requirements, general overview of class III/PMA device pathway, including IDE study and PMA submissions and best practices.

DR. SANJAY SHARMA IS HEAD OF REGULATORY AFFAIRS FOR ANEURYSM AND PERIPHERAL PRODUCTS AT MICROVENTION TERUMO. Over the past twenty years Sanjay held regulatory positions of increasing responsibility at various companies including, Boston Scientific Neuromodulation, Neuropace, Medtronic Neurovascular and Mainstay Medical. Prior to joining Microsection, Sanjay worked as VP of Regulatory Affairs and Quality at Mainstay Medical in San Diego. Prior to Mainstay Medical, Sanjay was leading aneurysm therapies regulatory portfolio at Medtronic Neurovascular in Irvine. Sanjay holds a PhD in Biochemical Engineering from Indian Institute of Technology, Delhi (India). In addition, Sanjay recently completed MBA from University of Illinois, Urbana Champaign. Sanjay is a RAC certified member of the Regulatory Affairs Professionals Society (RAPS) and holds RAC-US and RAC-EU certifications.

Dr. Maggie Chou currently serves as RA Manager at Microvention Terumo handling peripheral device portfolio. Prior to joining MicroVention, Maggie worked as a Principal RA Specialist at Boston Scientific, responsible for the pre-market and post-market (EU/US/CA) activities for neuromodulation implantable and non-implantable devices. Maggie had over 10 years of regulatory affairs experience including, 4 years in the pharmaceutical industry and over 6 years in medical devices. Maggie holds a PhD degree in Neuroscience and a MS degree in Regulatory Science from University of Southern California (USC), and she is a RAC certified member of the Regulatory Affairs Professionals Society (RAPS).

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SPONSOR: VALGENESIS

ValGenesis, Inc. is the creator of an innovative software platform that is a foundation for managing compliance-based validation activities in life sciences companies. ValGenesis VLMS is the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements.

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