David Pudwill, MS

Founder and Principal Consultant
FDA Blueprint

David Pudwill is a seasoned leader and regulatory expert who helps companies get medical devices and combination products to market. David is the founder and principal consultant of both Mr Regulatory and FDA Blueprint, providing training and consulting services to small and medium sized startups. David has served in senior leadership roles at AscentX Medical and ConvaTec, and previously worked at the U.S. Food and Drug Administration (FDA), and St. Jude Medical. He is a founding member of the Kidney Health Initiative, and has helped several startups acquire funding and successfully interact with FDA and the Department of Defense. While at FDA, David worked on DARPA projects and consulted with CBER and CDER regarding regulatory submissions, including clinical studies and marketing submissions, and reviewed FDA regulated software submissions as well as FDA regulated products that incorporated software functions.

David holds a Master of Mechanical Engineering from Johns Hopkins University, a BSE in Biomedical Engineering from Case Western Reserve University, and a Certificate from HBX, now Harvard Business School Online.

Presentation(s):

• Precision Medicine Using Companion Diagnostics, AI/ML Modeling, and Digital Health Technology? Buzzwords or Reality?

  Thursday, September 19, 2024
  3:15 PM – 4:15 PM PDT