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Wednesday, Apr 23rd
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
Breakout
Wednesday, Apr 23rd
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 – QualityHub, Inc.
Breakout
Wednesday, Apr 23rd
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 (he/him/his) – ACT-IVD
Speaker: David Murray – Illumina
Speaker: Michelle Zaharik – MLZ Biotech Consulting Inc
Breakout
Wednesday, Apr 23rd
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
Wednesday, Apr 23rd
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
Thursday, Apr 24th
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
Thursday, Apr 24th
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
Thursday, Apr 24th
12:30 PM – 2:00 PM East Coast USA Time
Breakout #1: QMSR - Are You Ready?
Location: Delaware AB – 2nd Floor
Moderator: Monica Wilkins – Abbott
Moderator: Kim Shoemaker – Johnson & Johnson MedTech
Speaker: Meera Bhatia – Abbott
Speaker: Patrick Weixel – Abbott
Breakout
Thursday, Apr 24th
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 – Retired, FDA
Breakout
Thursday, Apr 24th
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