MedCon Conference 2022
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.
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 Heath’s legacy of delivering the FDA/Xavier MedCon Conference.
The AFDO/RAPS Healthcare Products Collaborative reflects the commitment of both organizations to continue the important work Xavier Health has done to advance the industry. This new partnership will also produce Xavier Health’s other industry events—including the PharmaLink Conference, Combination Products Summit, and AI Summit.
Prior MedCon Conferences have been credited with providing open, transparent interactions with stakeholders, and the AFDO/RAPS Healthcare Products Collaborative plans to support and enhance these efforts. During the 2022 conference, attendees will:
Experience
Experience paradigm-shifting dialogue leading to practical solutions that can be implement immediately
LearN
Learn proactive and predictive methods to protect products, businesses, and patients.
GAIN
Gain cross-functional insights that foster critical alignment and collaboration across organization.
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.
Are you a current RAC holder?
Attend MedCon 2022 and earn 12.0 RAC recertification credits.
MedCon 2022 Speakers
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
Damien McPhillips
Director Quality, Global Software and Digital Health, Boston Scientific
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
Because of the generosity of our sponsors, we can continue our work to improve the healthcare products industry.
diamond SPONSORS
Gold SPONSORS
silver SPONSOR
If you would like to learn more about sponsorship opportunities, contact Patrick Flynn at 301-770-2920, ext. 246 or pflynn@raps.org.
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.
