I was joined by Mr. David Pudwill, a Regulatory Affairs expert for both medical devices as well as combination products.

David holds a Bachelor's Degree in Biomedical Engineering and his Masters in Mechanical Engineering. David actually spent 9 years of his career working directly for the FDA as a lead medical device reviewer. After that he spent several years with a med-tech organization called Convatec where he was responsible for developing and growing Global Regulatory and Quality teams as large as a hundred people worldwide, while developing new ways of thinking about Regulatory Affairs for both in market support as well as new product development and a digital transformation.

David currently runs a consulting/educational based firm called Mr. Regulatory. The organization really started as an educational platform primarily discus ...