Featured Speakers 2018

Featured
Jeff Shuren
Jeff Shuren

Director of the Center for Devices and Radiological Health (CDRH)

FDA

Dr. William Maisel
Dr. William Maisel

Assistant Director for Science, Office of the Center Director

FDA-CDRH

Gina Brackett
Gina Brackett

Director Compliance Branch and MedCon Co-Chair

FDA

Phil Pontikos
Phil Pontikos

National Device Expert

FDA

Marjorie Shulman
Marjorie Shulman

Chief of Premarket Notification (510(k)) Section, CDRH

FDA

Kim Trautman 
Kim Trautman 

Executive Vice President, Medical Device International Services

NSF

Agenda Highlights 2018

““There are always a lot of FDA people on-hand to be really frank and open; to have conversations.”

”
— Kim Trautman, Executive Vice President, Medical Device International Services NSF International

Actionable insights on these topics and more:

  • Center Director Corner: Strategic Priorities for 2018 and Beyond
  • FDA PostMarket Update and Strategic Priorities
  • FDA Rethinks Corrections & Removals: Workshop and Case Studies
  • IMDRF, Regulatory Convergence, and Practical Implementation
  • The CDRH 510(k) Review Template
  • How Medical Device Firms are Gearing Up for Compliance with Europe’s new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR)
  • Beyond Metrics Through the Power of Artificial Intelligence: Applications You Can Use in Quality Today
  • Investigator Insights and Breaking News

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.

Register now for MedCon 2019, happening April 30-May 3.

“Lots of great information in a very positive and collaborative environment.”
— MedCon 2017 Attendee

MedCon Attendees' Area of Expertise

By percentage

MedCon Attendees' Level of Expertise

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MedCon Attendees' Organization Size

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MedCon 2018 Sponsors

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

Experience the Xavier Difference

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

Inspiring Collaboration

“The list of presenters/subject experts were carefully selected to include individuals that were knowledgeable with current regulatory information, articulate and personable.”
— MedCon Attendee
  • 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.

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.