MedCon speakers are hand-selected by the MedCon Strategic Committee to deliver purpose-driven content that dives below the surface, challenges status quo, engages attendees in collaborative dialogue, and provides practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussions.
Felipe Aguel
FDA
Deputy Director, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH)
Edison Alverez
BD
Senior Director of Regulatory Strategic Planning for Cybersecurity at BD
Gert Bos
Qserve Group
Executive Director & Partner at Qserve Group
Sean Boyd
FDA
Director for the Office of Regulatory Programs Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Gina Brackett
FDA
Director for the Compliance Branch Division 1/East, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration
Bill Brodbeck
STERIS
Senior Director of Regulatory Affairs at STERIS Corporation
Jason Brooke
Brooke & Associates
Attorney & Managing Member at Brooke & Associates
Alex Cadotte
MCRA
Vice President, Digital Health, AI & Radiology
Daniel Canos
FDA
Director for the Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Kathryn Capanna
FDA
Associate Director of Strategic Development, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Paul Coplan
Johnson & Johnson Medtech
Vice President and Global Head, Medical Device Epidemiology
Benjamin Dastoli
FDA
Consumer Safety Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA)
Heidi Dohse
Tour de Heart
Founder and President at Tour de Heart
Aaron Dunbar
Boston Scientific
Vice President Quality Systems & Post Market at Boston Scientific
Jake Dyer
FDA
Regulatory Officer for the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Sonja Fulmer
FDA
Deputy Director for the Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Katie Furtick
Boston Scientific
Principal Quality Systems Engineer
Matt Gaf
Cook Medical
Quality Assurance & Global Quality Systems at Cook Medical
Laureen Geniusz
FDA
Consumer Safety Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA)
Augusto Geyer
ANVISA
General Manager of Medical Devices at Anvisa
JENNIFER GOODE
FDA
Biomedical Engineer for the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Alissa Hanna
Edwards Lifesciences
Director of Patient Engagement at Edwards Lifesciences
Kristen Hastings
Haemonetics
Director of Design Quality
Matt Hazelett
FDA
Cybersecurity Policy Analyst, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Eric Henry
King & Spalding
Senior Quality & Regulatory Compliance Advisor at King & Spalding LLP
Sabina Hoekstra -van den Bosch
TÜV SÜD Medical Health Services
Global Director, Regulatory Strategy
Shannon Hoste
Pathway for Patient Health
Chief Scientific Officer
diane johnson
Johnson & Johnson MedTech
Senior Director, North American Policy, Lead
Erez Kaminski
Ketryx
CEO & Founder at Ketryx
Mandar karhade
Citingale
Founder at Citingale
Erin Keith
FDA
Senior Advisor, Compliance and Quality Program, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Jim Kleinedler
Medtronic
Director, Regulatory Strategy at Medtronic
Tina Krenc
KTA Compliance Consulting
Principle Consultant at KTA Compliance Consulting
Mark Leahey
MDMA
President & CEO at Medical Device Manufacturers Association (MDMA)
Karen Masley-Joseph
FDA
Senior Advisor for Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration
Susan Matthias
FDA
CSO Special Assistant for Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration
Simon Mason
NESTcc part of MDIC
President
BRian McEvoy
Steris
Senior Director of Global Technologies at Steris Group
Tom McLain
Renalytix
President
Rhonda Mecl
FDA
Deputy Program Director, Medical Device and Radiological Health Operations, (OMDRHO), Office of Regulatory Affairs (ORA)
Sarah Sue Morbitzer
Ohio State University
Volleyball Player at Ohio State University
Josh Nipper
FDA
Director of Premarket Operations, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Ryan Ortega
FDA
Regulatory Policy Advisor, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Jessica Paulsen
FDA
Digital Health Associate Director for the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Yarmela Pavlovic
Medtronic
Vice President, Global Regulatory Affairs, Strategy & Policy
Thomas Peter
FDA
Medical Device Senior Operations Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA)
Lauren Priest
FDA
Medical Device Compliance Officer for the Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration
Phil Pontikos
FDA
Investigator, Medical Device National Expert, Division of Medical Products and Tobacco Program Operations Branch, Office of Regulatory Affairs (ORA)
Brian Putz
FDA
Public Health Service Supervisory Investigator for the Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration
Fatemeh Razjouyan
Medtronic
Director of Regulatory Policy, International and Harmonization, Global Regulatory Policy at Medtronic
Anne Reid
FDA
Program Director for the Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration
Thor Rollins
Nelson Labs
Vice President of Global Market Segment Leader-Medical Device at Nelson Labs
Heather Rosecrans
Greenleaf Health
Executive Vice President of Medical Devices & Combination Products at Greenleaf Health
Mike Ryan
FDA
Deputy Director for the Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
Emma Schaefer
FDA
Division Recall Coordinator Division I/East, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA)
Cassie Scherer
Medtronic
Senior Director of U.S. Regulatory and Global Digital Health Policy at Medtronic
Kim Shoemaker
Johnson & Johnson
Sr. Director of Global Regulatory Affairs at Ethicon
Jeff Shuren
FDA
Director of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Suzanne Schwartz
FDA
Director for the Office of Strategic Partnerships & Technology Innovation, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Tammy Steuerwald
Roche
Global Head of Regulatory Policy, Foundational Principles, and Supranational Organizations at Roche
Keisha Thomas
FDA
Director of Compliance and Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Kim Trautman
Medical Device, IVD and Combo Product Expert
Melissa Torres
FDA
Associate Director of International Affairs, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
April Veoukas
Abbott
Director, Regulatory Affairs
Colleen watson
Thermo Fisher Scientific
Senior Director, Regulatory Affairs
Monica Wilkins
Abbott
VP of Regulatory and Quality at Abbott
Jessica Zeller
Edwards Lifesciences
Vice President of Quality, Regulatory, Environmental, and Public Affairs Counsel at Edwards Lifesciences
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This conference WAs co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.
The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.