
Jeff Shuren
Director of the Center for Devices and Radiological Health (CDRH)
FDA

Dr. William Maisel
Assistant Director for Science, Office of the Center Director
FDA-CDRH

Gina Brackett
Director Compliance Branch and MedCon Co-Chair
FDA

Phil Pontikos
National Device Expert
FDA

Marjorie Shulman
Chief of Premarket Notification (510(k)) Section, CDRH
FDA

Kim Trautman
Executive Vice President, Medical Device International Services
NSF

Jan Welch (invited)
Director, Office of Medical Device and Radiological Health Operations
FDA

Steve Niedelman
Lead Quality System & Compliance Consultant
King & Spalding

Monica Wilkins
Divisional Vice President of Medical, Clinical, Quality and Strategic Support
Abbott

Heather Rosecrans
Executive VP, Medical Devices & Combination Products
Greenleaf Health

Susan Rolih
Executive Vice President, Regulatory and Quality Systems
Meridian Bioscience, Inc.

Jackie Rae Elkin
Global Process Owner - Standard Product Identification, Global Regulatory Affairs
Medtronic











