Conferences
Case for Quality Workshop
FDA/Xavier MedCon
AI Summit
Combination Products Summit
Combination Products Post-Summit Workshop
FDA/Xavier PharmaLink
Initiatives
Artificial Intelligence Initiative
Cincinnati Regional Chapter
Supply by Design Initiative
MDIC Device Metrics Initiative
Pharma Culture and Metrics Initiative
Learning
Case for Quality Workshop
Combination Products Post-Summit Workshop
Lunch & Learn Webinars
Webinar Toolbox
Contact

Xavier Health

Conferences
Case for Quality Workshop
FDA/Xavier MedCon
AI Summit
Combination Products Summit
Combination Products Post-Summit Workshop
FDA/Xavier PharmaLink
Initiatives
Artificial Intelligence Initiative
Cincinnati Regional Chapter
Supply by Design Initiative
MDIC Device Metrics Initiative
Pharma Culture and Metrics Initiative
Learning
Case for Quality Workshop
Combination Products Post-Summit Workshop
Lunch & Learn Webinars
Webinar Toolbox
Contact
Jeff Shuren

Jeff Shuren

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

FDA

Dr. William Maisel

Dr. William Maisel

Assistant Director for Science, Office of the Center Director

FDA-CDRH

Gina Brackett

Gina Brackett

Director Compliance Branch and MedCon Co-Chair

FDA

Phil Pontikos

Phil Pontikos

National Device Expert

FDA

Marjorie Shulman

Marjorie Shulman

Chief of Premarket Notification (510(k)) Section, CDRH

FDA

Kim Trautman 

Kim Trautman 

Executive Vice President, Medical Device International Services

NSF

Jan Welch (invited)

Jan Welch (invited)

Director, Office of Medical Device and Radiological Health Operations

FDA

Steve Niedelman

Steve Niedelman

Lead Quality System & Compliance Consultant

King & Spalding

Monica Wilkins 

Monica Wilkins 

Divisional Vice President of Medical, Clinical, Quality and Strategic Support

Abbott

Heather Rosecrans

Heather Rosecrans

Executive VP, Medical Devices & Combination Products

Greenleaf Health

Susan Rolih

Susan Rolih

Executive Vice President, Regulatory and Quality Systems

Meridian Bioscience, Inc.

Jackie Rae Elkin

Jackie Rae Elkin

Global Process Owner - Standard Product Identification, Global Regulatory Affairs

Medtronic

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Jeff Shuren
Dr. William Maisel
Gina Brackett
Phil Pontikos
Marjorie Shulman
Kim Trautman 
Jan Welch (invited)
Steve Niedelman
Monica Wilkins 
Heather Rosecrans
Susan Rolih
Jackie Rae Elkin
 
 
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