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 […]