For your convenience, the FDA/Xavier MedCon presentations are loaded onto this page as they are received from the presenters, unless a presenter has requested that their presentation not be posted. In keeping with Xavier’s conservation commitment, printed versions of presentations will not be available at the conference. If you have any questions, please contact Heather Harwood, Director, Art & Communications, at

2017 MedCon Presentations


Defending Claims for Your Device

Presenters: Jim O'Reilly; John Steiger

Impact of the New EU Regulations on Your Global Regulatory Strategy

Presenter: Phillipe Auclair

Meet ORA's Inaugural Ombudsmen

Presenter: Jessica Zeller

EU Regulations - Exploring the Unknown

Presenter: Gert Bos

Update from the Office of Device Evaluation

Presenter: Angela Krueger

Office of Compliance Strategic Priorities

Presenter: Robin Newman

Beyond Metrics: Using Artificial Intelligence to Advance the Predictive Capabilities of Your Organization

Presenter: John Daley

510(k) Modifications: To Submit or Not to Submit?

Steve Niedelman; Phil Phillips; Phil Pontikos; Heather Rosecrans; Michael Ryan; Angela Krueger; April Veoukas

Digital Health: Key Focus Areas for FDA and Industry

Presenter: Bakul Patel

Center Director Corner: Strategic Priorities for 2017 and Beyond

Presenter: Jeff Shuren

How to Measure Cultural Misalignment and Its Impact on Product Reliability

Presenter: Marla Phillips

The Convergence of International Regulatory Changes Through 2020

Presenter: Kim Trautman

What to Expect with FDA's Program Alignment

Presenter: Blake Bevill

Your Contract Manufacturer Received a Warning Letter. What Now?

Presenters: Francis Blacha; Michael Mascali; Patricia Murphy

FDA Insight on the 510(k) Modifications Guidance

Presenter: Michael Ryan

510(k): Who Needs One and What You Actually Own When You Have One

Presenters: Daniela Drago; Barbara Fant; Phil Phillips; Susan Rolih; Nancy Singer

Investigator Insights and Breaking News

Presenters: Gina Brackett; Ben Dastoli; Phil Pontikos