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A
Albert, Matt
Boston Scientific
Global Shift in Clinical Expectations
Matt Albert
B
Beckham, Tammy
FDA (invited)
Breakout #2: Supply Chain Resiliency: Evolving Challenges and Best Practices
Tammy Beckham
Belsky, Kim
AFDO/RAPS Healthcare Products Collaborative
Close-Out
Kim Belsky
Conference Close-Out
Kim Belsky
Day 2 Close
Kim Belsky
Let's Make a Difference!
Kim Belsky
Opening Day 2
Kim Belsky
Opening Day 3
Kim Belsky
Berlin, Lane
Grandview Heights Division of Fire
Patient Experience #2 Exploring Patient Experience
Lane Berlin
Bos, Gert
Qserve Group
Breakout #1: International: Experience and Challenges With MDR/IVDR and EUDAMED
Gert Bos
Global Shift in Clinical Expectations
Gert Bos
Bozsik, Balazs
SGS North America Inc.
Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements
Balazs Bozsik
Brackett, Gina
FDA (Invited)
Breakout #3: Are You Correctly Assessing Quality System Activities When Quality System Functions Are Spread Out Across Different Locations?
Gina Brackett
Breakout #3: Are You Processing and Investigating Complaints to the Right Level?
Gina Brackett
FDA Reorganization: The New Responsibilities of OMDRHI (Office of Medical Device and Radiological Health Inspectorate) and CDRH
Gina Brackett
Brodbeck, Bill
STERIS Corporation
Breakout #1: Addressing 510(k) Review Challenges
Bill Brodbeck
Breakout #2: Supply Chain Resiliency: Evolving Challenges and Best Practices
Bill Brodbeck
FDA Mock Inspection
Bill Brodbeck
The Device Design Change Life Cycle Experience
Bill Brodbeck
D
Dastoli, Benjamin
FDA
FDA Mock Inspection
Benjamin Dastoli
Investigator Insights
Benjamin Dastoli
Dunbar, Aaron
Boston Scientific
Breakout #3: Are You Processing and Investigating Complaints to the Right Level?
Aaron Dunbar
Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program
Aaron Dunbar
Global Shift in Clinical Expectations
Aaron Dunbar
Patient Experience Plenary #1
Aaron Dunbar
E
Elder, David
Eliquent Life Sciences
The Device Design Change Life Cycle Experience
David Elder
Escapule, Kevin
Zimmer Biomet
Global Shift in Clinical Expectations
Kevin Escapule
F
Fuh, Ken
ACT-IVD
Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements
Ken Fuh
G
Gallucci, Michael
Edwards Lifesciences
Breakout #2: Supply Chain Resiliency: Evolving Challenges and Best Practices
Michael Gallucci
Geniusz, Laureen
FDA
FDA Mock Inspection
Laureen Geniusz
Investigator Insights
Laureen Geniusz
Graf, Matt
Cook Medical
Breakout #2: Supply Chain Resiliency: Evolving Challenges and Best Practices
Matt Graf
H
Henry, Eric
King & Spalding
Breakout #2: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update
Eric Henry
Breakout #2: Implementation of Artificial Intelligence in Manufacturing and the Quality System
Eric Henry
Hoekstra-van den Bosch, Sabina
TÜV SÜD Medical Health Services
Breakout #1: International: Experience and Challenges With MDR/IVDR and EUDAMED
Sabina Hoekstra-van den Bosch
Hoste, Shannon
Pathway for Patient Health
Breakout #1: Risk Management - Systems Perspective
Shannon Hoste
Patient Experience #2 Exploring Patient Experience
Shannon Hoste
K
Kaplan, Kim
Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program
Kim Kaplan
Keith, Erin
FDA (Invited)
Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program
Erin Keith
Krug, John
Eli Lilly and Company
The Solutions Exchange – Culture of Quality
John Krug
L
Leahey, Mark
Medical Device Manufacturers Association (MDMA)
Breakout #3: What’s New in CDRH Premarket Programs: Insights and Updates From FDA and Industry Experts
Mark Leahey
M
Markley, Evan
Eli Lilly and Company
Breakout #1: Risk Management - Systems Perspective
Evan Markley
The Device Design Change Life Cycle Experience
Evan Markley
Matthias, Susan
FDA (Virtual)
FDA Reorganization: The New Responsibilities of OMDRHI (Office of Medical Device and Radiological Health Inspectorate) and CDRH
Susan Matthias
McCann, Mindy
Qserve Group
Global Shift in Clinical Expectations
Mindy McCann
Mecl, Rhonda
FDA (Virtual)
FDA Medical Device Inspections
Rhonda Mecl
FDA Reorganization: The New Responsibilities of OMDRHI (Office of Medical Device and Radiological Health Inspectorate) and CDRH
Rhonda Mecl
Murray III, Clarence
STERIS Corporation
Breakout #1: Addressing 510(k) Review Challenges
Clarence Murray III
N
Nadig, Chitra
KeborMed
The Device Design Change Life Cycle Experience
Chitra Nadig
Nipper, Josh
FDA (Invited)
Breakout #3: What’s New in CDRH Premarket Programs: Insights and Updates From FDA and Industry Experts
Josh Nipper
Noffs, Karen
Anvisa
Breaking Barriers: The Power of Regulatory Reliance
Karen Noffs
P
Perez, Commander Cesar
FDA (Invited)
FDA Reorganization: The New Responsibilities of OMDRHI (Office of Medical Device and Radiological Health Inspectorate) and CDRH
Commander Cesar Perez
Piotrkowski, Tony
Steris
Breakout #1: Addressing 510(k) Review Challenges
Tony Piotrkowski
The Device Design Change Life Cycle Experience
Tony Piotrkowski
Pontikos, Phil
FDA
Breakout #3: Are You Processing and Investigating Complaints to the Right Level?
Phil Pontikos
FDA Mock Inspection
Phil Pontikos
FDA Medical Device Inspections
Phil Pontikos
Investigator Insights
Phil Pontikos
The Device Design Change Life Cycle Experience
Phil Pontikos
Post, Justin
FDA (Invited)
Breakout #2: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update
Justin Post
R
Razjouyan, Fatemeh
Medtronic
Breaking Barriers: The Power of Regulatory Reliance
Fatemeh Razjouyan
Reed, Chris
Medtronic
Breakout #2: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update
Chris Reed
Reid, Anne
FDA (Virtual)
FDA Medical Device Inspections
Anne Reid
FDA Reorganization: The New Responsibilities of OMDRHI (Office of Medical Device and Radiological Health Inspectorate) and CDRH
Anne Reid
Rosecrans, Heather
Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
Breakout #1: Addressing 510(k) Review Challenges
Heather Rosecrans
Breakout #3: What’s New in CDRH Premarket Programs: Insights and Updates From FDA and Industry Experts
Heather Rosecrans
S
Schultz, Brian
Fisher & Paykel Healthcare
Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program
Brian Schultz
Schultz, Dan
Eliquent Life Sciences
Breakout #3: What’s New in CDRH Premarket Programs: Insights and Updates From FDA and Industry Experts
Dan Schultz
Shoemaker, Kim
Johnson & Johnson MedTech
Breakout #1: International: Experience and Challenges With MDR/IVDR and EUDAMED
Kim Shoemaker
Breakout #3: Are You Correctly Assessing Quality System Activities When Quality System Functions Are Spread Out Across Different Locations?
Kim Shoemaker
Siroka, Brian
MEDIcept
Breakout #1: Risk Management - Systems Perspective
Brian Siroka
Sperezel, John
T2 Biosystems
Patient Experience Plenary #1
John Sperezel
Steuerwald, Tammy
Roche
Breaking Barriers: The Power of Regulatory Reliance
Tammy Steuerwald
T
Thomas, Keisha
FDA (Invited)
Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program
Keisha Thomas
Torres, Melissa
FDA (Invited)
Breaking Barriers: The Power of Regulatory Reliance
Melissa Torres
Trautman, Kim
Medical Device, IVD and Combo Product Expert
Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements
Kim Trautman
The Solutions Exchange – Culture of Quality
Kim Trautman
V
Vincent Griffin, Lisa
GT Metabolic Solutions
Breakout #1: Addressing 510(k) Review Challenges
Lisa Vincent Griffin
W
Wilkins, Monica
Abbott
Breakout #3: Are You Correctly Assessing Quality System Activities When Quality System Functions Are Spread Out Across Different Locations?
Monica Wilkins
Breakout #3: Are You Processing and Investigating Complaints to the Right Level?
Monica Wilkins
Breakout #3: Due Diligence – Are You Doing Enough? What About After Acquisition?
Monica Wilkins
Investigator Insights
Monica Wilkins
Wirth, Axel
MedCrypt
Breakout #2: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update
Axel Wirth
Z
Zaharik, Michelle
MLZ Biotech Consulting Inc
Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements
Michelle Zaharik
Zeller, Jessica
Edwards Lifesciences
The Solutions Exchange – Culture of Quality
Jessica Zeller
