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Wednesday, April 23, 2025
7:00 AM – 8:00 AM
East Coast USA Time
Breakfast
7:00 AM – 8:00 AM
East Coast USA Time
Breakfast
Location: Regency Ballroom Foyer – 3rd Floor
7:00 AM – 5:00 PM
East Coast USA Time
Registration
7:00 AM – 5:00 PM
East Coast USA Time
Registration
Location: Regency Ballroom Foyer – 3rd Floor
8:00 AM – 8:20 AM
East Coast USA Time
Let's Make a Difference!
8:00 AM – 8:20 AM
East Coast USA Time
Let's Make a Difference!
Location: Regency Ballroom – 3rd Floor
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Speaker:
Steven Mandernach
– Association of Food and Drug Officials (AFDO)
Speaker:
Bill McMoil
– Regulatory Affairs Professionals Society, RAPS (Welcome)
Plenary
8:25 AM – 8:55 AM
East Coast USA Time
Patient Experience Plenary #1
8:25 AM – 8:55 AM
East Coast USA Time
Patient Experience Plenary #1
Location: Regency Ballroom – 3rd Floor
Moderator:
Aaron Dunbar
– Boston Scientific
Speaker:
John Sperezel, III
– T2 Biosystems, Inc.
Plenary
9:00 AM – 9:45 AM
East Coast USA Time
The Solutions Exchange – Culture of Quality
9:00 AM – 9:45 AM
East Coast USA Time
The Solutions Exchange – Culture of Quality
Location: Regency Ballroom – 3rd Floor
Moderator:
John Krug
– Eli Lilly and Company
Moderator:
Kim Trautman
– Medical Device, IVD and Combo Product Expert
Moderator:
Jessica Zeller
– Edwards Lifesciences
Plenary
9:45 AM – 10:05 AM
East Coast USA Time
BREAK
9:45 AM – 10:05 AM
East Coast USA Time
BREAK
Location: Regency Ballroom Foyer – 3rd Floor
10:05 AM – 10:50 AM
East Coast USA Time
FDA Medical Device Inspections
10:05 AM – 10:50 AM
East Coast USA Time
FDA Medical Device Inspections
Location: Regency Ballroom – 3rd Floor
Moderator:
Susan Matthias
– FDA (Virtual)
Moderator:
Phil Pontikos
– FDA
Speaker:
Anne Reid
– FDA (Virtual)
Speaker:
Rhonda Mecl
– FDA (Virtual)
Plenary
10:55 AM – 11:40 PM
East Coast USA Time
Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program
10:55 AM – 11:40 AM
East Coast USA Time
Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program
Location: Regency Ballroom – 3rd Floor
Moderator:
Aaron Dunbar
– Boston Scientific
Speaker:
Kim Kaplan
– ISACA
Speaker:
Erin Keith (she/her/hers)
– FDA (Virtual)
Speaker:
Roseanne Leaupepe
– Fisher & Paykel Healthcare
Speaker:
Keisha Thomas, MS, MHS, CQA, RAC
– FDA (Virtual)
Plenary
11:40 AM – 12:55 PM
East Coast USA Time
LUNCH
11:40 AM – 12:45 PM
East Coast USA Time
LUNCH
Location: Franklin A-C – 2nd Floor
12:45 PM – 2:00 PM
East Coast USA Time
Breakout #1: International: Experience and Challenges With MDR/IVDR and EUDAMED
12:45 PM – 2:00 PM
East Coast USA Time
Breakout #1: International: Experience and Challenges With MDR/IVDR and EUDAMED
Location: Delaware AB – 2nd Floor
Moderator:
Gert Bos
– Qserve Group
Moderator:
Kim Shoemaker
– Johnson & Johnson MedTech
Speaker:
Sabina Hoekstra-van den Bosch
– TÜV SÜD Medical Health Services
Speaker:
Nick-Roy Green
– Johnson & Johnson MedTech
Speaker:
João Martins
– Abbott
Breakout
12:45 PM – 2:00 PM
East Coast USA Time
Breakout #2: What’s New in CDRH Premarket Programs: Insights and Updates From Industry Experts
12:45 PM – 2:00 PM
East Coast USA Time
Breakout #2: What’s New in CDRH Premarket Programs
Location: Delaware CD – 2nd Floor
Moderator:
Heather Rosecrans
– Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
Speaker:
Mark Leahey
– Medical Device Manufacturers Association (MDMA)
Speaker:
Dan Schultz
– Eliquent Life Sciences
Speaker:
Sean Boyd
– Quality Hub
Breakout
2:00 PM – 2:15 PM
East Coast USA Time
BREAK
2:00 PM – 2:15 PM
East Coast USA Time
BREAK
Location: Delaware Foyer – 2nd Floor
2:15 PM – 3:15 PM
East Coast USA Time
Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements
2:15 PM – 3:15 PM
East Coast USA Time
Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements
Location: Delaware AB – 2nd Floor
Moderator:
Kim Trautman
– Medical Device, IVD and Combo Product Expert
Speaker:
Balazs Bozsik
– SGS North America Inc.
Speaker:
Ken Fuh
– ACT-IVD
Speaker:
David Murray
– Illumina
Speaker:
Michelle Zaharik
– MLZ Biotech Consulting Inc
Breakout
2:15 PM – 3:15 PM
East Coast USA Time
Breakout #2: Are You Correctly Assessing Quality System Activities When Quality System Functions Are Spread Out Across Different Locations?
2:15 PM – 3:15 PM
East Coast USA Time
Breakout #2: Are You Correctly Assessing Quality System Activities When Quality System Functions Are Spread Out Across Different Locations?
Location: Delaware CD – 2nd Floor
Moderator:
Gert Bos
– Qserve Group
Speaker:
Monica Wilkins
– Abbott
Speaker:
Kim Shoemaker
– Johnson & Johnson MedTech
Breakout
2:15 PM – 3:15 PM
East Coast USA Time
Breakout #3: Supply Chain Resiliency: Evolving Challenges and Best Practices
2:15 PM – 3:15 PM
East Coast USA Time
Breakout #3: Supply Chain Resiliency: Evolving Challenges and Best Practices
Location: Regency Ballroom – 3rd Floor
Moderator:
Bill Brodbeck
– STERIS Corporation
Speaker:
Michael Gallucci
– Edwards Lifesciences
Speaker:
Matt Graf
– Cook Medical
Breakout
3:15 PM – 3:30 PM
East Coast USA Time
BREAK and move back to plenary
3:15 PM – 3:30 PM
East Coast USA Time
BREAK
Location: Regency Foyer – 3rd Floor
3:30 PM – 4:15 PM
East Coast USA Time
FDA’s QMSR Implementation Status
3:30 PM – 4:15 PM
East Coast USA Time
FDA’s QMSR Implementation Status
Location: Regency Ballroom – 3rd Floor
Moderator:
Phil Pontikos
– FDA
Speaker:
Keisha Thomas, MS, MHS, CQA, RAC
– FDA (Virtual)
Speaker:
Karen Masley-Joseph
– FDA (Virtual)
Plenary
4:15 PM – 5:00 PM
East Coast USA Time
Fireside Chat with Industry Leaders
4:15 PM – 4:55 PM
East Coast USA Time
Fireside Chat with Industry Leaders
Location: Regency Ballroom – 3rd Floor
Moderator:
Jessica Zeller
– Edwards Lifesciences
Speaker:
Bill Brodbeck
– STERIS Corporation
Speaker:
Aaron Dunbar
– Boston Scientific
Speaker:
Shannon Hoste
– Pathway for Patient Health
Plenary
5:00 PM – 5:05 PM
East Coast USA Time
Close-Out
5:00 PM – 5:05 PM
East Coast USA Time
Close-Out
Location: Regency Ballroom – 3rd Floor
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Plenary
6:00 PM – 8:30 PM
East Coast USA Time
MedCon Annual Dinner - Ticketed Event
6:00 PM – 8:30 PM
East Coast USA Time
MedCon Annual Dinner - Ticketed Event
Networking Event
