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Breakout
Wednesday, Apr 23rd
1:20 PM – 2:35 PM
East Coast USA Time
Breakout #1: International: Experience and Challenges With MDR/IVDR and EUDAMED
Moderator:
Gert Bos
– Qserve Group
Moderator:
Kim Shoemaker
– Johnson & Johnson MedTech
Speaker:
Sabina Hoekstra-van den Bosch
– TÜV SÜD Medical Health Services
Breakout
Wednesday, Apr 23rd
1:20 PM – 2:35 PM
East Coast USA Time
Breakout #2: Implementation of Artificial Intelligence in Manufacturing and the Quality System
Moderator:
Eric Henry
– King & Spalding
Breakout
Wednesday, Apr 23rd
1:20 PM – 2:35 PM
East Coast USA Time
Breakout #3: What’s New in CDRH Premarket Programs: Insights and Updates From FDA and Industry Experts
Moderator:
Heather Rosecrans
– Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
Speaker:
Mark Leahey
– Medical Device Manufacturers Association (MDMA)
Speaker:
Josh Nipper
– FDA (Invited)
Speaker:
Dan Schultz
– Eliquent Life Sciences
Breakout
Wednesday, Apr 23rd
2:55 PM – 3:55 PM
East Coast USA Time
Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements
Moderator:
Kim Trautman
– Medical Device, IVD and Combo Product Expert
Speaker:
Ken Fuh
– ACT-IVD
Speaker:
Michelle Zaharik
– MLZ Biotech Consulting Inc
Speaker:
Balazs Bozsik
– SGS North America Inc.
Breakout
Wednesday, Apr 23rd
2:55 PM – 3:55 PM
East Coast USA Time
Breakout #2: Supply Chain Resiliency: Evolving Challenges and Best Practices
Moderator:
Bill Brodbeck
– STERIS Corporation
Speaker:
Tammy Beckham
– FDA (invited)
Speaker:
Michael Gallucci
– Edwards Lifesciences
Speaker:
Matt Graf
– Cook Medical
Breakout
Wednesday, Apr 23rd
2:55 PM – 3:55 PM
East Coast USA Time
Breakout #3: Are You Correctly Assessing Quality System Activities When Quality System Functions Are Spread Out Across Different Locations?
Moderator:
Gina Brackett
– FDA (Invited)
Speaker:
Monica Wilkins
– Abbott
Speaker:
Kim Shoemaker
– Johnson & Johnson MedTech
Breakout
Thursday, Apr 24th
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #1: Risk Management - Systems Perspective
Moderator:
Shannon Hoste
– Pathway for Patient Health
Speaker:
Brian Siroka
– MEDIcept
Speaker:
Evan Markley
– Eli Lilly and Company
Breakout
Thursday, Apr 24th
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #2: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update
Moderator:
Eric Henry
– King & Spalding
Speaker:
Axel Wirth
– MedCrypt
Speaker:
Justin Post
– FDA (Invited)
Speaker:
Chris Reed
– Medtronic
Breakout
Thursday, Apr 24th
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #3: Due Diligence – Are You Doing Enough? What About After Acquisition?
Moderator:
Monica Wilkins
– Abbott
Breakout
Thursday, Apr 24th
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #2 QMSR Are You Ready?
Breakout
Thursday, Apr 24th
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #1: Addressing 510(k) Review Challenges
Moderator:
Bill Brodbeck
– STERIS Corporation
Moderator:
Heather Rosecrans
– Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
Speaker:
Clarence Murray III
– STERIS Corporation
Speaker:
Tony Piotrkowski
– Steris
Speaker:
Lisa Vincent Griffin
– GT Metabolic Solutions
Breakout
Thursday, Apr 24th
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #3: Are You Processing and Investigating Complaints to the Right Level?
Moderator:
Gina Brackett
– FDA (Invited)
Speaker:
Monica Wilkins
– Abbott
Speaker:
Aaron Dunbar
– Boston Scientific
Speaker:
Phil Pontikos
– FDA
Breakout
Networking Event
Tuesday, Apr 22nd
5:30 PM – 6:30 PM
East Coast USA Time
Opening Reception
Networking Event
Wednesday, Apr 23rd
6:00 PM – 8:30 AM
East Coast USA Time
MedCon Annual Dinner
Networking Event
Thursday, Apr 24th
5:30 PM – 7:00 PM
East Coast USA Time
Networking Reception
Networking Event
Plenary
Wednesday, Apr 23rd
8:00 AM – 8:20 AM
East Coast USA Time
Let's Make a Difference!
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Plenary
Wednesday, Apr 23rd
8:25 AM – 8:55 AM
East Coast USA Time
Patient Experience Plenary #1
Moderator:
Aaron Dunbar
– Boston Scientific
Speaker:
John Sperezel
– T2 Biosystems
Plenary
Wednesday, Apr 23rd
9:00 AM – 9:30 AM
East Coast USA Time
The Solutions Exchange – Culture of Quality
Moderator:
John Krug
– Eli Lilly and Company
Moderator:
Kim Trautman
– Medical Device, IVD and Combo Product Expert
Moderator:
Jessica Zeller
– Edwards Lifesciences
Plenary
Wednesday, Apr 23rd
9:50 AM – 10:25 AM
East Coast USA Time
Center Director Corner: CDRH Strategic Priorities and Initiatives for 2025 and Beyond
Plenary
Wednesday, Apr 23rd
10:30 AM – 11:05 AM
East Coast USA Time
FDA Medical Device Inspections
Moderator:
Phil Pontikos
– FDA
Speaker:
Anne Reid
– FDA (Virtual)
Speaker:
Rhonda Mecl
– FDA (Virtual)
Plenary
Wednesday, Apr 23rd
11:10 AM – 11:40 AM
East Coast USA Time
FDA Reorganization: The New Responsibilities of OMDRHI (Office of Medical Device and Radiological Health Inspectorate) and CDRH
Moderator:
Gina Brackett
– FDA (Invited)
Moderator:
Susan Matthias
– FDA (Virtual)
Speaker:
Rhonda Mecl
– FDA (Virtual)
Speaker:
Commander Cesar Perez
– FDA (Invited)
Speaker:
Anne Reid
– FDA (Virtual)
Plenary
Wednesday, Apr 23rd
11:45 AM – 12:15 PM
East Coast USA Time
Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program
Moderator:
Aaron Dunbar
– Boston Scientific
Speaker:
Kim Kaplan
Speaker:
Erin Keith
– FDA (Invited)
Speaker:
Brian Schultz
– Fisher & Paykel Healthcare
Speaker:
Keisha Thomas
– FDA (Invited)
Plenary
Wednesday, Apr 23rd
4:20 PM – 5:05 PM
East Coast USA Time
TBD
Plenary
Wednesday, Apr 23rd
5:10 PM – 5:15 PM
East Coast USA Time
Close-Out
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Plenary
Thursday, Apr 24th
8:00 AM – 8:10 AM
East Coast USA Time
Opening Day 2
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Plenary
Thursday, Apr 24th
8:15 AM – 9:30 AM
East Coast USA Time
Breaking Barriers: The Power of Regulatory Reliance
Moderator:
Fatemeh Razjouyan
– Medtronic
Speaker:
Melissa Torres
– FDA (Invited)
Speaker:
Karen Noffs
– Anvisa
Speaker:
Tammy Steuerwald
– Roche
Plenary
Thursday, Apr 24th
2:25 PM – 4:25 PM
East Coast USA Time
FDA Mock Inspection
Moderator:
Phil Pontikos
– FDA
Speaker:
Laureen Geniusz
– FDA
Speaker:
Benjamin Dastoli
– FDA
Speaker:
Bill Brodbeck
– STERIS Corporation
Plenary
Thursday, Apr 24th
4:30 PM – 5:00 PM
East Coast USA Time
Patient Experience #2 Exploring Patient Experience
Moderator:
Shannon Hoste
– Pathway for Patient Health
Speaker:
Lane Berlin
– Grandview Heights Division of Fire
Plenary
Thursday, Apr 24th
5:00 PM – 5:10 PM
East Coast USA Time
Day 2 Close
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Plenary
Friday, Apr 25th
8:00 AM – 8:05 AM
East Coast USA Time
Opening Day 3
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Plenary
Friday, Apr 25th
8:10 AM – 9:10 AM
East Coast USA Time
Global Shift in Clinical Expectations
Moderator:
Aaron Dunbar
– Boston Scientific
Moderator:
Gert Bos
– Qserve Group
Speaker:
Kevin Escapule
– Zimmer Biomet
Speaker:
Mindy McCann
– Qserve Group
Speaker:
Matt Albert
– Boston Scientific
Plenary
Friday, Apr 25th
9:35 AM – 11:35 AM
East Coast USA Time
Investigator Insights
Moderator:
Monica Wilkins
– Abbott
Speaker:
Benjamin Dastoli
– FDA
Speaker:
Laureen Geniusz
– FDA
Speaker:
Phil Pontikos
– FDA
Plenary
Workshop
Tuesday, Apr 22nd
8:30 AM – 4:30 PM
East Coast USA Time
The Device Design Change Life Cycle Experience
Moderator:
Bill Brodbeck
– STERIS Corporation
Speaker:
David Elder
– Eliquent Life Sciences
Speaker:
Evan Markley
– Eli Lilly and Company
Speaker:
Chitra Nadig
– KeborMed
Speaker:
Tony Piotrkowski
– Steris
Speaker:
Phil Pontikos
– FDA
Workshop
