MedCon 2017 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. MedCon 2017 Supporting Documents:
Speakers Session Title Presentation
Jim O'Reilly and John Steiger Defending Claims for Your Device
Phillipe Auclair Impact of the New EU Regulations on Your Global Regulatory Strategy
Jessica Zeller Meet ORA's Inaugural Ombudsmen
Gert Bos EU Regulations - Exploring the Unknown
Angela Krueger Update from the Office of Device Evaluation
Robin Newman Office of Compliance Strategic Priorities
John Daley Beyond Metrics: Using Artificial Intelligence to Advance the Predictive Capabilities of Your Organization
Steve Niedelman, Phil Phillips, Phil Pontikos, Heather Rosecrans, Michael Ryan, Angela Krueger, April Veoukas 510(k) Modifications: To Submit or Not to Submit?
Bakul Patel Digital Health- Key Focus Areas for FDA and Industry
Jeff Shuren Center Director Corner: Strategic Priorities for 2017 and Beyond
Marla Phillips How to Measure Cultural Misalignment and Its Impact on Product Reliability
Kim Trautman The Convergence of International Regulatory Changes Through 2020
Blake Bevill What to Expect with FDA's Program Alignment
Francis Blacha, Michael Mascali, Patricia Murphy Your Contract Manufacturer Received a Warning Letter. What Now?
Michael Ryan FDA Insight on the 510(k) Modifications Guidance
Daniela Drago, Barbara Fant, Phil Phillips, Susan Rolih, Nancy Singer 510(k): Who Needs One and What You Actually Own When You Have One
Gina Brackett, Ben Dastoli, Phil Pontikos Investigator Insights and Breaking News