Executive Vice President, Medical Devices & Combination Products
Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
Heather Rosecrans brings more than 40 years of public
health, and particularly medical device experience, to MDMA and ELIQUENT Life Sciences.
Prior to joining MDMA and ELIQUENT, Heather spent 33+ years at the U.S. FDA’s Center for Devices and Radiological Health (CDRH). Heather served for her last 18 years at CDRH as Director of the Premarket Notification (510(k)) Staff. In this role, she was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions and other premarket regulatory requirements.
The Device Design Change Life Cycle Experience
Tuesday, April 22, 2025
8:30 AM – 4:30 PM East Coast USA Time
Breakout #2: What’s New in CDRH Premarket Programs
Wednesday, April 23, 2025
12:45 PM – 2:00 PM East Coast USA Time
Breakout #3: Addressing 510(k) Review Challenges
Thursday, April 24, 2025
12:30 PM – 2:00 PM East Coast USA Time