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Tuesday, April 22, 2025
7:30 AM – 8:30 AM
East Coast USA Time
Breakfast
7:30 AM – 8:30 AM
East Coast USA Time
Breakfast
Location: Franklin A – 2nd Floor
8:30 AM – 4:30 PM
East Coast USA Time
The Device Design Change Life Cycle Experience
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 (he/him/his)
– Eliquent Life Sciences
Moderator:
Eric Henry
– King & Spalding LLP
Speaker:
Evan Markley
– Eli Lilly and Company
Speaker:
Chitra Nadig
– KeborMed
Speaker:
Tony Piotrkowski
– STERIS Corporation
Speaker:
Phil Pontikos
– FDA
Speaker:
Heather Rosecrans
– Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
Workshop
5:30 PM – 6:30 PM
East Coast USA Time
Opening Reception
5:30 PM – 6:30 PM
East Coast USA Time
Opening Reception
Networking Event
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
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!
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
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
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
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
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
Moderator:
Aaron Dunbar
– Boston Scientific
Speaker:
Kim Kaplan
– ISACA
Speaker:
Erin Keith (she/her/hers)
– FDA (Virtual)
Speaker:
Brian Schultz
– 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
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
Moderator:
Gert Bos
– Qserve Group
Moderator:
Kim Shoemaker
– Johnson & Johnson MedTech
Speaker:
Sabina Hoekstra-van den Bosch
– TÜV SÜD Medical Health Services
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
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
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
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?
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
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
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
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 AM
East Coast USA Time
Fireside Chat with Industry Leaders
Moderator:
Jessica Zeller
– Edwards Lifesciences
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
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Plenary
6:00 PM – 8:30 PM
East Coast USA Time
MedCon Annual Dinner
6:00 PM – 8:30 PM
East Coast USA Time
MedCon Annual Dinner
Networking Event
Thursday, April 24, 2025
7:00 AM – 8:00 AM
East Coast USA Time
Breakfast
7:00 AM – 8:00 AM
East Coast USA Time
Breakfast
8:00 AM – 8:10 AM
East Coast USA Time
Opening Day 2
8:00 AM – 8:10 AM
East Coast USA Time
Opening Day 2
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Plenary
8:15 AM – 9:30 AM
East Coast USA Time
Breaking Barriers: The Power of Regulatory Reliance
8:15 AM – 9:30 AM
East Coast USA Time
Breaking Barriers: The Power of Regulatory Reliance
Moderator:
Fatemeh Razjouyan
– Medtronic
Speaker:
Karen Noffs
– Anvisa - Brazil
Speaker:
Tammy Steuerwald
– Roche
Plenary
9:30 AM – 9:50 AM
East Coast USA Time
BREAK
9:30 AM – 9:50 AM
East Coast USA Time
BREAK
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #1: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #1: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update
Moderator:
Eric Henry
– King & Spalding LLP
Speaker:
Axel Wirth
– MedCrypt
Speaker:
Chris Reed
– Medtronic
Breakout
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #2: Due Diligence – Are You Doing Enough? What About After Acquisition?
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #2: Due Diligence – Are You Doing Enough? What About After Acquisition?
Moderator:
Monica Wilkins
– Abbott
Speaker:
Braulio Ortiz
– BioTeknica
Speaker:
Dennett Kouri
– Edwards Lifesciences
Breakout
11:25 AM – 12:25 PM
East Coast USA Time
LUNCH
11:25 AM – 12:25 PM
East Coast USA Time
LUNCH
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #1: QMSR - Are You Ready?
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #1: QMSR - Are You Ready?
Moderator:
Kim Shoemaker
– Johnson & Johnson MedTech
Speaker:
Meera Bhatia
– Abbott
Speaker:
Patrick Weixel
– Abbott
Breakout
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #2: Are You Processing and Investigating Complaints to the Right Level?
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #2: Are You Processing and Investigating Complaints to the Right Level?
Moderator:
Kim Trautman
– Medical Device, IVD and Combo Product Expert
Speaker:
Monica Wilkins
– Abbott
Speaker:
Aaron Dunbar
– Boston Scientific
Speaker:
Phil Pontikos
– FDA
Breakout
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #3: Addressing 510(k) Review Challenges
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #3: 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 Corporation
Speaker:
Lisa Griffin Vincent (she/her/hers)
– GT Metabolic Solutions, Inc.
Speaker:
Liz Claverie-Williams
– Claverie & Associates Consulting, LLC
Breakout
2:00 PM – 2:20 PM
East Coast USA Time
BREAK
2:00 PM – 2:20 PM
East Coast USA Time
BREAK
2:25 PM – 3:55 PM
East Coast USA Time
Risk Management - Systems Perspective
2:25 PM – 3:55 PM
East Coast USA Time
Risk Management - Systems Perspective
Moderator:
Shannon Hoste
– Pathway for Patient Health
Speaker:
Brian Siroka
– MEDIcept
Speaker:
Evan Markley
– Eli Lilly and Company
Speaker:
David Murray
– Illumina
Plenary
4:00 PM – 4:30 PM
East Coast USA Time
Patient Experience Plenary, #2 Exploring Patient Experience
4:00 PM – 4:30 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
4:30 PM – 4:40 PM
East Coast USA Time
Day 2 Close
4:30 PM – 4:40 PM
East Coast USA Time
Day 2 Close
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Plenary
4:45 PM – 6:00 PM
East Coast USA Time
Networking Reception
4:45 PM – 6:00 PM
East Coast USA Time
Networking Reception
Networking Event
Friday, April 25, 2025
7:00 AM – 8:00 PM
East Coast USA Time
Breakfast
7:00 AM – 8:00 AM
East Coast USA Time
Breakfast
8:00 AM – 8:05 AM
East Coast USA Time
Opening Day 3
8:00 AM – 8:05 AM
East Coast USA Time
Opening Day 3
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Plenary
8:10 AM – 9:25 AM
East Coast USA Time
Global Shift in Clinical Expectations
8:10 AM – 9:25 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
9:25 AM – 9:45 AM
East Coast USA Time
BREAK
9:25 AM – 9:45 AM
East Coast USA Time
BREAK
9:35 AM – 11:35 AM
East Coast USA Time
Investigator Insights
9:50 AM – 11:20 AM
East Coast USA Time
Investigator Insights
Moderator:
Monica Wilkins
– Abbott
Speaker:
Laureen Geniusz
– FDA (Virtual)
Speaker:
Susan Matthias
– FDA (Virtual)
Speaker:
CDR Tom Peter
– FDA (Virtual)
Speaker:
Katelyn Staub-Zamperini
– FDA (Virtual)
Speaker:
LCDR Mary Millner
– FDA (Virtual)
Plenary
11:25 AM – 11:30 AM
East Coast USA Time
Conference Close-Out
11:25 AM – 11:30 AM
East Coast USA Time
Conference Close-Out
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
