Speaker List

Senior Fellow, Corporate Clinical Quality
Boston Scientific

Office Director, Office of Supply Chain Resilience, Office of Strategic Partnership and Technology Innovation (OST), Center for Devices and Radiological Health (CDRH)
FDA (invited)

Strategic Facilitator
AFDO/RAPS Healthcare Products Collaborative

Captain
Grandview Heights Division of Fire

Ohio, United States

Executive Director & Partner
Qserve Group

Technical Director - Medical Audit
SGS North America Inc.

Assistant Director, Establishment Assessment Team 1, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Invited)

Vice President, Regulatory Affairs
STERIS Corporation

Ohio, United States

Consumer Safety Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA

Vice President of Quality Systems & Post Market
Boston Scientific

Principal, Quality & Compliance
Eliquent Life Sciences

Vice President Quality Assurance
Zimmer Biomet

IVD and MDSW Expert
ACT-IVD

Alberta, Canada

VP Strategic Sourcing
Edwards Lifesciences

Consumer Safety Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA

Corporate Director, Quality Assurance & Global Quality Systems
Cook Medical

Indiana, United States

Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice
King & Spalding

Global Director Regulatory Strategy
TÜV SÜD Medical Health Services

Chief Scientific Officer
Pathway for Patient Health

Senior Advisor, Compliance and Quality Program, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Invited)

Executive Director and Site Quality Leader of Indianapolis Device Manufacturing
Eli Lilly and Company

President & CEO
Medical Device Manufacturers Association (MDMA)

Associate Director Digital Health Solution Delivery
Eli Lilly and Company

Senior Advisor, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA (Invited)

Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA (Virtual)

Vice President US Operations and Principal Consultant
Qserve Group

Deputy Program Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA (Virtual)

Director, Regulatory Affairs
STERIS Corporation

Director of Quality and Regulatory
KeborMed

Director, PreMarket Operations, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Invited)

General Manager, Office of Medical Devices
Anvisa

Director, Division of Establishment Support, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Invited)

Director of Regulatory Affairs
Steris

Investigator, Medical Device National Expert, Office of Inspections and Investigations (OII), Office of Medical Device and Radiological Health Inspectorate (OMDRHI)
FDA

Cybersecurity Policy Analyst, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Invited)

Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy
Medtronic

Senior Director of Cybersecurity Policy, Global Regulatory Affairs
Medtronic

Office Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA (Virtual)

Executive Vice President, Medical Devices & Combination Products
Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA

Vice President of Quality, Safety & Regulatory Affairs
Fisher & Paykel Healthcare

Principal, Medical Devices & Combination Products
Eliquent Life Sciences

Senior Director, Global Regulatory Affairs
Johnson & Johnson MedTech

Associate Medical Device Consultant
MEDIcept

Chairman and CEO
T2 Biosystems

Global Head of Regulatory Policy, Foundational Principles and Supranational Organizations
Roche

Director of Compliance and Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Invited)

Associate Director for International Affairs, Center for Devices and Radiological Health (CDRH)
FDA (Invited)

Expert
Medical Device, IVD and Combo Product Expert

Chief Regulatory, Quality, Clinical
GT Metabolic Solutions

VP Regulatory and Quality
Abbott

Chief Security Strategist
MedCrypt

Independent Expert
MLZ Biotech Consulting Inc

Vice President, Quality & Regulatory Counsel
Edwards Lifesciences