Skip to main content
Toggle navigation
Login
Search
Home
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Full Schedule
Home
Full Schedule
All Days
Tue, Apr 22
Wed, Apr 23
Thu, Apr 24
Fri, Apr 25
Full Schedule
Type here to filter the list
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
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 – 8:10 AM
East Coast USA Time
Opening Day 2
8:00 AM – 8:10 AM
East Coast USA Time
Opening Day 2
Location: Regency Ballroom – 3rd Floor
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
Location: Regency Ballroom – 3rd Floor
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
Location: Regency Ballroom Foyer – 3rd Floor
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
Location: Delaware AB – 2nd Floor
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?
Location: Delaware CD – 2nd Floor
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
Location: Franklin A-C – 2nd Floor
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?
Location: Delaware AB – 2nd Floor
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?
Location: Delaware CD – 2nd Floor
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
Location: Regency Ballroom – 3rd Floor
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. (virtual)
Speaker:
Liz Claverie-Williams (she/her/hers)
– 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
Location: Regency Ballroom Foyer – 3rd Floor
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
Location: Regency Ballroom – 3rd Floor
Moderator:
Shannon Hoste
– Pathway for Patient Health
Moderator:
John Krug
– Eli Lilly and Company
Moderator:
Kim Trautman
– Medical Device, IVD and Combo Product Expert
Moderator:
Bill Brodbeck
– STERIS Corporation
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
Location: Regency Ballroom – 3rd Floor
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
Location: Regency Ballroom – 3rd Floor
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
Location: Regency Ballroom Foyer – 3rd Floor
Networking Event
