---
bio: 'David Pudwill is a seasoned leader and regulatory expert who helps companies
  get innovative medical devices and combination products to market. 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.'
hire_date: '2026-06-09'
hobbies: ''
linkedin: https://www.linkedin.com/in/david-pudwill/
name: David Pudwill
photo: /img/people/David_Pudwill-37abd5b7a754805ca4aee666d7d37550.jpg
skills: FDA Regulatory Strategy, Medical Devices, Combination Products, FDA Submissions,
  Clinical Studies, FDA-Regulated Software
testimonials: []
title: Medical Device Regulatory Expert
---