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Breaking Barriers: The Power of Regulatory Reliance

Fatemeh Razjouyan – Medtronic ### 2544314###Moderator###Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy###Medtronic###
Moderator: Fatemeh Razjouyan – Medtronic
### @@@ Melissa Torres – FDA (Invited) ### 2591602###Speaker###Associate Director for International Affairs, Center for Devices and Radiological Health (CDRH)###FDA (Invited)###
Speaker: Melissa Torres – FDA (Invited)
### @@@ Karen Noffs – Anvisa ### 2591584###Speaker###General Manager, Office of Medical Devices###Anvisa###
Speaker: Karen Noffs – Anvisa
### @@@ Tammy Steuerwald – Roche ### 2591593###Speaker###Global Head of Regulatory Policy, Foundational Principles and Supranational Organizations###Roche###
Speaker: Tammy Steuerwald – Roche
###
Breakout #2 QMSR Are You Ready?
Breakout #1: Addressing 510(k) Review Challenges

Bill Brodbeck – STERIS Corporation ### 2544305###Moderator###Vice President, Regulatory Affairs###STERIS Corporation###
Moderator: Bill Brodbeck – STERIS Corporation
### @@@ Heather Rosecrans – Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA ### 2544311###Moderator###Executive Vice President, Medical Devices & Combination Products###Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA###
Moderator: Heather Rosecrans – Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
### @@@ Clarence Murray III – STERIS Corporation ### 2608391###Speaker###Director, Regulatory Affairs###STERIS Corporation###
Speaker: Clarence Murray III – STERIS Corporation
### @@@ Tony Piotrkowski – Steris ### 2591586###Speaker###Director of Regulatory Affairs###Steris###
Speaker: Tony Piotrkowski – Steris
### @@@ Lisa Vincent Griffin – GT Metabolic Solutions ### 2591603###Speaker###Chief Regulatory, Quality, Clinical###GT Metabolic Solutions###
Speaker: Lisa Vincent Griffin – GT Metabolic Solutions
###
Breakout #1: International: Experience and Challenges With MDR/IVDR and EUDAMED

Gert Bos – Qserve Group ### 2544966###Moderator###Executive Director & Partner###Qserve Group###
Moderator: Gert Bos – Qserve Group
### @@@ Kim Shoemaker – Johnson & Johnson MedTech ### 2544967###Moderator###Senior Director, Global Regulatory Affairs###Johnson & Johnson MedTech###
Moderator: Kim Shoemaker – Johnson & Johnson MedTech
### @@@ Sabina Hoekstra-van den Bosch – TÜV SÜD Medical Health Services ### 2591571###Speaker###Global Director Regulatory Strategy###TÜV SÜD Medical Health Services###
Speaker: Sabina Hoekstra-van den Bosch – TÜV SÜD Medical Health Services
###
Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements

Kim Trautman – Medical Device, IVD and Combo Product Expert ### 2544312###Moderator###Expert###Medical Device, IVD and Combo Product Expert###
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
### @@@ Ken Fuh – ACT-IVD ### 2591570###Speaker###IVD and MDSW Expert###ACT-IVD###
Speaker: Ken Fuh – ACT-IVD
### @@@ Michelle Zaharik – MLZ Biotech Consulting Inc ### 2591605###Speaker###Independent Expert###MLZ Biotech Consulting Inc###
Speaker: Michelle Zaharik – MLZ Biotech Consulting Inc
### @@@ Balazs Bozsik – SGS North America Inc. ### 2607208###Speaker###Technical Director - Medical Audit###SGS North America Inc.###
Speaker: Balazs Bozsik – SGS North America Inc.
###
Breakout #1: Risk Management - Systems Perspective

Shannon Hoste – Pathway for Patient Health ### 2544316###Moderator###Chief Scientific Officer###Pathway for Patient Health###
Moderator: Shannon Hoste – Pathway for Patient Health
### @@@ Brian Siroka – MEDIcept ### 2591591###Speaker###Associate Medical Device Consultant###MEDIcept###
Speaker: Brian Siroka – MEDIcept
### @@@ Evan Markley – Eli Lilly and Company ### 2591578###Speaker###Associate Director Digital Health Solution Delivery###Eli Lilly and Company###
Speaker: Evan Markley – Eli Lilly and Company
###
Breakout #2: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update

Eric Henry – King & Spalding ### 2482790###Moderator###Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice###King & Spalding###
Moderator: Eric Henry – King & Spalding
### @@@ Axel Wirth – MedCrypt ### 2591604###Speaker###Chief Security Strategist###MedCrypt###
Speaker: Axel Wirth – MedCrypt
### @@@ Justin Post – FDA (Invited) ### 2591587###Speaker###Cybersecurity Policy Analyst, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)###FDA (Invited)###
Speaker: Justin Post – FDA (Invited)
### @@@ Chris Reed – Medtronic ### 2591588###Speaker###Senior Director of Cybersecurity Policy, Global Regulatory Affairs###Medtronic###
Speaker: Chris Reed – Medtronic
###
Breakout #2: Implementation of Artificial Intelligence in Manufacturing and the Quality System

Eric Henry – King & Spalding ### 2482790###Moderator###Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice###King & Spalding###
Moderator: Eric Henry – King & Spalding
###
Breakout #2: Supply Chain Resiliency: Evolving Challenges and Best Practices

Bill Brodbeck – STERIS Corporation ### 2544305###Moderator###Vice President, Regulatory Affairs###STERIS Corporation###
Moderator: Bill Brodbeck – STERIS Corporation
### @@@ Tammy Beckham – FDA (invited) ### 2591566###Speaker###Office Director, Office of Supply Chain Resilience, Office of Strategic Partnership and Technology Innovation (OST), Center for Devices and Radiological Health (CDRH)###FDA (invited)###
Speaker: Tammy Beckham – FDA (invited)
### @@@ Michael Gallucci – Edwards Lifesciences ### 2591572###Speaker###VP Strategic Sourcing###Edwards Lifesciences###
Speaker: Michael Gallucci – Edwards Lifesciences
### @@@ Matt Graf – Cook Medical ### 2591574###Speaker###Corporate Director, Quality Assurance & Global Quality Systems###Cook Medical###
Speaker: Matt Graf – Cook Medical
###
Breakout #3: Are You Correctly Assessing Quality System Activities When Quality System Functions Are Spread Out Across Different Locations?

Gina Brackett – FDA (Invited) ### 2544310###Moderator###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)###
Moderator: Gina Brackett – FDA (Invited)
### @@@ Monica Wilkins – Abbott ### 2544317###Speaker###VP Regulatory and Quality###Abbott###
Speaker: Monica Wilkins – Abbott
### @@@ Kim Shoemaker – Johnson & Johnson MedTech ### 2544967###Speaker###Senior Director, Global Regulatory Affairs###Johnson & Johnson MedTech###
Speaker: Kim Shoemaker – Johnson & Johnson MedTech
###
Breakout #3: Are You Processing and Investigating Complaints to the Right Level?

Gina Brackett – FDA (Invited) ### 2544310###Moderator###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)###
Moderator: Gina Brackett – FDA (Invited)
### @@@ Monica Wilkins – Abbott ### 2544317###Speaker###VP Regulatory and Quality###Abbott###
Speaker: Monica Wilkins – Abbott
### @@@ Aaron Dunbar – Boston Scientific ### 2544307###Speaker###Vice President of Quality Systems & Post Market###Boston Scientific###
Speaker: Aaron Dunbar – Boston Scientific
### @@@ Phil Pontikos – FDA ### 2544315###Speaker###Investigator, Medical Device National Expert, Office of Inspections and Investigations (OII), Office of Medical Device and Radiological Health Inspectorate (OMDRHI)###FDA###
Speaker: Phil Pontikos – FDA
###
Breakout #3: Due Diligence – Are You Doing Enough? What About After Acquisition?

Monica Wilkins – Abbott ### 2544317###Moderator###VP Regulatory and Quality###Abbott###
Moderator: Monica Wilkins – Abbott
###
Breakout #3: What’s New in CDRH Premarket Programs: Insights and Updates From FDA and Industry Experts

Heather Rosecrans – Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA ### 2544311###Moderator###Executive Vice President, Medical Devices & Combination Products###Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA###
Moderator: Heather Rosecrans – Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
### @@@ Mark Leahey – Medical Device Manufacturers Association (MDMA) ### 2591577###Speaker###President & CEO###Medical Device Manufacturers Association (MDMA)###
Speaker: Mark Leahey – Medical Device Manufacturers Association (MDMA)
### @@@ Josh Nipper – FDA (Invited) ### 2591583###Speaker###Director, PreMarket Operations, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)###FDA (Invited)###
Speaker: Josh Nipper – FDA (Invited)
### @@@ Dan Schultz – Eliquent Life Sciences ### 2606027###Speaker###Principal, Medical Devices & Combination Products###Eliquent Life Sciences###
Speaker: Dan Schultz – Eliquent Life Sciences
###
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Center Director Corner: CDRH Strategic Priorities and Initiatives for 2025 and Beyond
Close-Out

Kim Belsky – AFDO/RAPS Healthcare Products Collaborative ### 2544306###Speaker###Strategic Facilitator###AFDO/RAPS Healthcare Products Collaborative###
Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
###
Conference Close-Out

Kim Belsky – AFDO/RAPS Healthcare Products Collaborative ### 2544306###Speaker###Strategic Facilitator###AFDO/RAPS Healthcare Products Collaborative###
Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
###
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Day 2 Close

Kim Belsky – AFDO/RAPS Healthcare Products Collaborative ### 2544306###Speaker###Strategic Facilitator###AFDO/RAPS Healthcare Products Collaborative###
Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
###
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FDA Mock Inspection

Phil Pontikos – FDA ### 2544315###Moderator###Investigator, Medical Device National Expert, Office of Inspections and Investigations (OII), Office of Medical Device and Radiological Health Inspectorate (OMDRHI)###FDA###
Moderator: Phil Pontikos – FDA
### @@@ Laureen Geniusz – FDA ### 2591573###Speaker###Consumer Safety Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA###
Speaker: Laureen Geniusz – FDA
### @@@ Benjamin Dastoli – FDA ### 2591567###Speaker###Consumer Safety Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA###
Speaker: Benjamin Dastoli – FDA
### @@@ Bill Brodbeck – STERIS Corporation ### 2544305###Speaker###Vice President, Regulatory Affairs###STERIS Corporation###
Speaker: Bill Brodbeck – STERIS Corporation
###
FDA Medical Device Inspections

Phil Pontikos – FDA ### 2544315###Moderator###Investigator, Medical Device National Expert, Office of Inspections and Investigations (OII), Office of Medical Device and Radiological Health Inspectorate (OMDRHI)###FDA###
Moderator: Phil Pontikos – FDA
### @@@ Anne Reid – FDA (Virtual) ### 2591589###Speaker###Office Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Anne Reid – FDA (Virtual)
### @@@ Rhonda Mecl – FDA (Virtual) ### 2591581###Speaker###Deputy Program Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Rhonda Mecl – FDA (Virtual)
###
FDA Reorganization: The New Responsibilities of OMDRHI (Office of Medical Device and Radiological Health Inspectorate) and CDRH

Gina Brackett – FDA (Invited) ### 2544310###Moderator###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)###
Moderator: Gina Brackett – FDA (Invited)
### @@@ Susan Matthias – FDA (Virtual) ### 2544309###Moderator###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)###
Moderator: Susan Matthias – FDA (Virtual)
### @@@ Rhonda Mecl – FDA (Virtual) ### 2591581###Speaker###Deputy Program Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Rhonda Mecl – FDA (Virtual)
### @@@ Commander Cesar Perez – FDA (Invited) ### 2591585###Speaker###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)###
Speaker: Commander Cesar Perez – FDA (Invited)
### @@@ Anne Reid – FDA (Virtual) ### 2591589###Speaker###Office Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Anne Reid – FDA (Virtual)
###
Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program

Aaron Dunbar – Boston Scientific ### 2544307###Moderator###Vice President of Quality Systems & Post Market###Boston Scientific###
Moderator: Aaron Dunbar – Boston Scientific
### @@@ Kim Kaplan ### 2616090###Speaker#########
Speaker: Kim Kaplan
### @@@ Erin Keith – FDA (Invited) ### 2591576###Speaker###Senior Advisor, Compliance and Quality Program, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)###FDA (Invited)###
Speaker: Erin Keith – FDA (Invited)
### @@@ Brian Schultz – Fisher & Paykel Healthcare ### 2591590###Speaker###Vice President of Quality, Safety & Regulatory Affairs###Fisher & Paykel Healthcare###
Speaker: Brian Schultz – Fisher & Paykel Healthcare
### @@@ Keisha Thomas – FDA (Invited) ### 2591601###Speaker###Director of Compliance and Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)###FDA (Invited)###
Speaker: Keisha Thomas – FDA (Invited)
###
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Global Shift in Clinical Expectations

Aaron Dunbar – Boston Scientific ### 2544307###Moderator###Vice President of Quality Systems & Post Market###Boston Scientific###
Moderator: Aaron Dunbar – Boston Scientific
### @@@ Gert Bos – Qserve Group ### 2544966###Moderator###Executive Director & Partner###Qserve Group###
Moderator: Gert Bos – Qserve Group
### @@@ Kevin Escapule – Zimmer Biomet ### 2591569###Speaker###Vice President Quality Assurance###Zimmer Biomet###
Speaker: Kevin Escapule – Zimmer Biomet
### @@@ Mindy McCann – Qserve Group ### 2591580###Speaker###Vice President US Operations and Principal Consultant###Qserve Group###
Speaker: Mindy McCann – Qserve Group
### @@@ Matt Albert – Boston Scientific ### 2591565###Speaker###Senior Fellow, Corporate Clinical Quality###Boston Scientific###
Speaker: Matt Albert – Boston Scientific
###
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Investigator Insights

Monica Wilkins – Abbott ### 2544317###Moderator###VP Regulatory and Quality###Abbott###
Moderator: Monica Wilkins – Abbott
### @@@ Benjamin Dastoli – FDA ### 2591567###Speaker###Consumer Safety Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA###
Speaker: Benjamin Dastoli – FDA
### @@@ Laureen Geniusz – FDA ### 2591573###Speaker###Consumer Safety Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA###
Speaker: Laureen Geniusz – FDA
### @@@ Phil Pontikos – FDA ### 2544315###Speaker###Investigator, Medical Device National Expert, Office of Inspections and Investigations (OII), Office of Medical Device and Radiological Health Inspectorate (OMDRHI)###FDA###
Speaker: Phil Pontikos – FDA
###
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Let's Make a Difference!

Kim Belsky – AFDO/RAPS Healthcare Products Collaborative ### 2544306###Speaker###Strategic Facilitator###AFDO/RAPS Healthcare Products Collaborative###
Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
###
LUNCH
LUNCH
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MedCon Annual Dinner
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Networking Reception
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Opening Day 2

Kim Belsky – AFDO/RAPS Healthcare Products Collaborative ### 2544306###Speaker###Strategic Facilitator###AFDO/RAPS Healthcare Products Collaborative###
Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
###
Opening Day 3

Kim Belsky – AFDO/RAPS Healthcare Products Collaborative ### 2544306###Speaker###Strategic Facilitator###AFDO/RAPS Healthcare Products Collaborative###
Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
###
Opening Reception
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Patient Experience Plenary #1

Aaron Dunbar – Boston Scientific ### 2544307###Moderator###Vice President of Quality Systems & Post Market###Boston Scientific###
Moderator: Aaron Dunbar – Boston Scientific
### @@@ John Sperezel – T2 Biosystems ### 2591594###Speaker###Chairman and CEO###T2 Biosystems###
Speaker: John Sperezel – T2 Biosystems
###
Patient Experience #2 Exploring Patient Experience

Shannon Hoste – Pathway for Patient Health ### 2544316###Moderator###Chief Scientific Officer###Pathway for Patient Health###
Moderator: Shannon Hoste – Pathway for Patient Health
### @@@ Lane Berlin – Grandview Heights Division of Fire ### 2591606###Speaker###Captain###Grandview Heights Division of Fire###
Speaker: Lane Berlin – Grandview Heights Division of Fire
###
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TBD
The Device Design Change Life Cycle Experience

Bill Brodbeck – STERIS Corporation ### 2544305###Moderator###Vice President, Regulatory Affairs###STERIS Corporation###
Moderator: Bill Brodbeck – STERIS Corporation
### @@@ David Elder – Eliquent Life Sciences ### 2591568###Speaker###Principal, Quality & Compliance###Eliquent Life Sciences###
Speaker: David Elder – Eliquent Life Sciences
### @@@ Evan Markley – Eli Lilly and Company ### 2591578###Speaker###Associate Director Digital Health Solution Delivery###Eli Lilly and Company###
Speaker: Evan Markley – Eli Lilly and Company
### @@@ Chitra Nadig – KeborMed ### 2591582###Speaker###Director of Quality and Regulatory###KeborMed###
Speaker: Chitra Nadig – KeborMed
### @@@ Tony Piotrkowski – Steris ### 2591586###Speaker###Director of Regulatory Affairs###Steris###
Speaker: Tony Piotrkowski – Steris
### @@@ Phil Pontikos – FDA ### 2544315###Speaker###Investigator, Medical Device National Expert, Office of Inspections and Investigations (OII), Office of Medical Device and Radiological Health Inspectorate (OMDRHI)###FDA###
Speaker: Phil Pontikos – FDA
###
The Solutions Exchange – Culture of Quality

John Krug – Eli Lilly and Company ### 2562427###Moderator###Executive Director and Site Quality Leader of Indianapolis Device Manufacturing###Eli Lilly and Company###
Moderator: John Krug – Eli Lilly and Company
### @@@ Kim Trautman – Medical Device, IVD and Combo Product Expert ### 2544312###Moderator###Expert###Medical Device, IVD and Combo Product Expert###
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
### @@@ Jessica Zeller – Edwards Lifesciences ### 2562430###Moderator###Vice President, Quality & Regulatory Counsel###Edwards Lifesciences###
Moderator: Jessica Zeller – Edwards Lifesciences
###