Featured Speakers


Agenda Highlights

“There are always a lot of FDA people on-hand to be really frank and open; to have conversations.”
— Kim Trautman, Executive VP, Medical Device International Services, NSF International

Solutions for Today

  • Best Practices for Submission Success

  • FDA Mock Inspection

  • To Recall or Not Recall

  • FDARA Impacts You

  • Are There Complaints Hiding in the Shadows?

  • Preparing Clinical Evaluations

  • Risk Culture

  • MDSAP

  • Lessons Learned from EU MDR: Prepping for IVDR

  • Journey of Cybersecurity for Medical Devices

Solutions for Tomorrow

  • From the Office of Jeff Shuren: Strategic Priorities for 2020 and Beyond

  • From the Office of Jan Welch: Initiatives to Advance Public Health

  • From the Office of Sean Boyd: Increasing Speed to Market

  • From the Field: Preparing for Tomorrow Utilizing FDA Investigator Insights

  • Factory of the Future - 3D Printing and Mobile Manufacturing

  • Virtual Reality: Hands-On Demo

  • Quality’s Role: Paradigm-Shift in the 21st Century

  • Breakthrough Device Program: The Catalyst for Market Access

  • The New World Order After BREXIT

  • FDA Innovation Challenge Program for a Better Tomorrow


In the Medical Device Industry? You Need to Be at Xavier.

MedCon 2017

The FDA/Xavier University Medical Device Conference, MedCon, is a conference with formal FDA partnership that engages medical device manufacturers in discussion on how to increase the consistency and reliability of product quality while complying with FDA regulations.

Plan on attending MedCon 2020, happening May 5-8.

This has been one of the best conferences that I have attended.
— MedCon 2019 Attendee

MedCon Attendees' Area of Expertise

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MedCon Attendees' Level of Expertise

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MedCon Attendees' Organization Size

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MedCon 2020 Sponsors

Because of the generosity of our sponsors, we can continue our work to improve the medical device industry. Thank you!

Distinguished Sponsors —


Experience the Xavier Difference

There are three key outcomes that we look to deliver through MedCon:

Inspiring Collaboration

  • Feel the purpose-driven nature of this summit as soon as you enter the room.

  • Expect orchestrated engagement with your peers across the industry on topics you are passionate about.

  • Find attendees openly sharing their expertise to help advance the industry in collaboration with regulators.

  • Work side-by-side with regulators to deepen the understanding on both sides of challenges and opportunities.

The balance of FDA and industry is perfect. Plus it’s great to network with such a broad range of attendees.
— MedCon 2019 Attendee

Leading Innovation

  • Identify solutions that will protect your patients around the world, your company brand, and your business.

  • Talk about the “elephant in the room” to get to the real pain that plagues our industry.

  • Learn what you didn’t know you didn’t know! Walk away with real solutions.

  • Hear directly from speakers who passionately challenge the status quo.

Making a Difference

  • Work through real working models that can improve the reliability of your product…today.

  • Learn how you can be part of the solution.

  • Understand who your stakeholders are so you can implement meaningful and sustainable change.

  • Leave the conference armed with action plans that are orchestrated throughout the summit and solidified before you leave.