Presentations

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 Stacie Ball, Program Manager at 513-745-3483 or balls2@xavier.edu. Archived Presentations:  To access past MedCon Presentations visit our archives page.
Below are the MedCon 2016 Presentations:
Speakers Session Title Presentation
Jeff Shuren Center Director Corner: Strategic Priorities for 2016 and Beyond
Robin Newman Office of Compliance Strategic Priorities
Susumu Nozawa Navigating Japan’s Regulatory Environment
Bakul Patel FDA and International Update on Cybersecurity Progress
Bill Maisel, Barbara Fant, Alan Rae and Rick D'Augustine Regulatory Strategy for Innovation
Gina Brackett, Bill Brodbeck, Steve Niedelman and Monica Wilkins Working through Challenges with Supplier Quality and Design-What to do and When
Dennis Hahn, Steve Niedelman, Susan Rolih, Heather Rosecrans and Nancy Singer Critical Thinking-The Secret to Responding to FDA
Marla Phillips and Michael Landberg Paradigm Shift - Meaningful Solutions for your Supply Chain
Paul Brooks European Medical Device Regulation Progress
Kim Trautman and Nancy Shadeed Canada’s changing Quality System Requirements: 13485/MDSAP/CMDCAS
Jon Steiger and Deborah Wolf Internet and Social Media Concerns – FDA and FTC Perspectives
Kristin McNamara and Marla Phillips MDIC/Xavier University Medical Device Metrics Initiative
Bill Maisel Update from the Office of Device Evaluation
Phil Phillips, April Veoukas, and Michael Ryan When to File a 510(k) for Modifications to your Cleared Device – What you don’t know can hurt you
Bob Banta, Romain Marmot, Marilyn Waxberg and Barbara Fant You Really want to store Clinical Data in The Cloud?
Jan Welch What to Expect with FDA’s Program Alignment?
Gina Brackett and Ben Dastoli Investigator Insights (Breaking News)