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MedCon 2024, co-sponsored by the FDA

MedCon took place April 24-26, 2024

Columbus, OH

Speakers & Moderators from MedCon 2024

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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