MedCon Conference 2023
Since 2009, MedCon has united regulators and healthcare products industry experts for unparalleled exchanges.
For the first time since 2019, MedCon reunited in-person April 24-27, 2023 for three days of purpose-driven discussions that harmonize different perspectives to inspire collaboration, lead innovation, and make a difference in patient care. The event was hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services.
if YOU MISSED THIS YEAR’S MEDCON, here’s what we covered —
MedCon 2023 by the #s
50
speakers
15
moderators
30+
FDA speakers
26
sessions
4
tracks
300+
attendees
42
FDA participants
26
sessions
…and 14 countries across 5 continents
An experience like no other!
Full-day risk management pre-conference workshop and two-and-a-half-day, in-depth Conference
Paradigm-shifting dialogue leading to practical solutions that can be implemented immediately
Proactive and predictive methods to protect products, businesses, and patients
Cross-functional insights that fostered critical alignment and collaboration across organizations
“The MedCon Conference helps fulfill the Department of Health and Human Servcies’ and FDA’s important mission to protect public health.”
Gina Brackett
Director, Compliance Branch FDA ORA Office of Medical Device and Radiological Health
Past Program Lineup
Our 2023 lineup enabled attendees to engage and contribute in plenaries aimed at breaking barriers and solving problems, along with in-depth breakouts and the Solutions Exchange!
Sessions included:
- Returning to the New Normal in the Face of Evolving Challenges: Update from CDRH Director, Jeff Shuren
- Medical Device User Fee Amendment (MDUFA) V: How Is It Impacting FDA Staff, Industry, and Patients?
- Office of Regulatory Affairs (ORA) Office of Medical Device and Radiological Health Update
- Finding Common Ground: Managing Device Interoperability Expectations
- Situation in UK & Switzerland
- Sustainability Throughout the Supply Chain: FDA and Industry Perspectives
- FDA Transition to ISO 13485/Update on Proposed Rule Aligning QSR With 13485 (QMSR)
- Global Regulatory Convergence and Shaping Innovation
- Innovating Submission of Premarket Applications – CDRH Portal and eSTAR Program
- Demonstration of FDA Databases and Publicly Available Tools
Past Speaker Highlights
Jeff Shuren
Director of the Center for Devices and Radiological Health (CDRH), FDA
Elizabeth Miller
Assistant Commissioner for Medical Products and Tobacco Operations, FDA-ORA
Monica Wilkins
Vice President Regulatory and Quality, Abbott
Sabina Hoekstra-van den Bosch
Global Director Regulatory Strategy, TÜV SÜD Medical Health Services
Kim Trautman
Managing Director and Vice President, MEDIcept Inc.
Keisha Thomas
Associate Director for Compliance and Quality, CDRH, FDA
Douglas Kelly
Deputy Center Director for Science Office of the Center Director, CDRH, FDA
Phil Pontikos
National Expert, OMDRHO – ORA, FDA (Invited)
Heather Rosencrans
Executive Vice President, Medical Devices & Combination Products, Greenleaf Health
Vice President Regulatory Affairs, MDMA
MedCon attendees were able to earn 12.0 RAC recertification credits.
Past Sponsors
Because of the generosity of our sponsors, we can continue our work to improve the healthcare products industry.
Diamond Sponsor
Platinum Sponsor
Platinum Sponsor
Gold Sponsor
Gold Sponsor
Gold Sponsor
Gold Sponsor
Silver SPONSOR
Silver Sponsor
Silver SPONSOR
Learn more about supporting MedCon through sponsorship by contacting Patrick Flynn at 301-770-2920, ext. 246 or pflynn@healthcareproducts.org.
This conference is co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.
