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2022 MedCon Homepage

The premier medical device conference driving the speed of innovation.

At MedCon, global regulators and medical device manufacturers engage to increase speed to market and product quality through innovation.

This year’s success by the numbers:

400+ participants

22 sessions

4 tracks

70+ speakers

25 FDA speakers, along with other government regulators

Experience dialogue leading to practical solutions you can implement today.

Learn proactive and predictive methods to protect your products, your business, and your patients.

Gain cross-functional insights that foster critical alignment and collaboration across your organization.

RAPS Regulatory Affairs Certificate (white)

Are you a current RAC holder? 

Attend MedCon 2022 and earn 12.0 RAC recertification credits. 

2022 Speakers

Jeff Shuren, Director of the Center for Devices and Radiological Health, FDA-CDRH

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

Melissa Kann

Director, Regulatory Affairs, Stryker

Nicole Taylor-Smith

Vice President, Global Regulatory Policy, Medtronic

Gina Brackett, OMDRHO Division 1 Director, Compliance Branch and MedCon Co-Chair, FDA-ORA

Gina Brackett

OMDRHO Division 1 Director, Compliance Branch and MedCon Co-Chair, FDA-ORA

Damien McPhillips

Director Quality, Global Software and Digital Health, Boston Scientific

Keisha Thomas, Associate Director for Compliance and Quality, FDA - CDRH

Keisha Thomas

Associate Director for Compliance and Quality, FDA – CDRH

2022 Main Conference Sessions

Latest on FDA programs and plans, insightful speakers, roadmaps to accelerate innovation, including:

  • CDRH’s Strategic Direction for 2022
  • FDA Proposed QMSR – Updating 21 CFR 820 to Harmonize with ISO 13485:2016
  • EU MDR Implementation: First Lessons Learned
  • UK MHRA and Swiss Medic Medical Device Registrations – Are You in Compliance?
  • Cybersecurity: Holistic Strategies to Mitigate and Manage Risk
  • Biocompatibility and Premarket Submissions
  • Global Developments in Regulating AI Based Medical Devices
  • The Connected Journey of Data, Metrics, KPIs and CAPA 
  • Investigator Insights
  • And more!

2022 MedCon Sponsors

diamond SPONSORS

silver SPONSOR

If you would like to learn more about sponsorship opportunities, contact Patrick Flynn at 301-770-2920, ext. 246 or

Meet The New Conference Facilitators

The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community. With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Health’s legacy of delivering the MedCon Conference.

In 2022, this conference was 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.