S1:E7 | #7 – Solving FDA Regulatory Puzzles With Roxanne Dubois

UMN Roxanne Dubois | FDA Regulatory Puzzles

  Roxanne Dubois has represented medical device companies as the primary liaison with the FDA and Notified Bodies for over 25 years. Roxanne forms collaborative working relationships with representatives of regulatory agencies to obtain clearance/approval for 510(k)s, IDEs, PMAs, and Design Dossiers for new medical devices and device modifications. Roxanne has hands-on experience writing regulatory […]

S1:E5 | #5 – Product Design Solves Problems With Shig Tanaka

UMN Shig | Product Design

Shig Tanaka is the Vice President of Research & Development at Providence Medical Technology. He was the Co-founder of Prospect+Health and lead engineer of Kolum, Inc (acquired).   Shig graduated from Stanford University with a degree in Product Design. His interests in mathematics, problem solving, and mechanical engineering were an ideal fit for the emerging field […]