For your convenience the presentations that will be made at MedCon are loaded onto this page as we receive them from the presenters, unless a presenter has requested 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 Mason Rick, Program Manager, at 513-745-3016 or
To access past MedCon Presentations visit our archives page.
Below are the MedCon 2015 Presentations:
Speakers Session Title Presentation
Thinh Nguyen & John "Barr" Weiner Update from FDA’s Office of Combination Products
Jeff Shuren Center Director Corner: Strategic Priorities for 2015 and Beyond
Jan Welch Office of Compliance Strategic Priorities
Francis Blacha, Marian Lee, Bob Banta, Bradley Thompson, & Spencer Timmel Advancements in Medical Device Software Technology
Kim Trautman, Scott Sardeson, & Bill Brodbeck Understanding & Preparing for the Revision of ISO13485
Jay Crowley UDI – Implementation “Ain’t” Easy
Monica Wilkins, Susan Rolih, Cynthia Ipach, & Steve Niedelman FDA 483 Observations: What to Do and How to Do It
Paul Brooks & John Brennan EU Medical Device/IVD Regulation Review
Kim Trautman Understanding the Current Activities of the International Medical Device Regulators Forum (IMDRF)
Bill Maisel Update from the Office of Device Evaluation
Monica Wilkins, Steve Niedelman, Phil Pontikos, Gina Brackett, & Bill Brodbeck Complaints, CAPAs, Recalls – What to Do and When
Barbara Zimmerman & Quynh Hoang Increase Speed to Market with an Effective Regulatory Strategy
Marjorie Shulman Improving your Chance of 510(k) Success
Evangeline Loh Understanding the Regulatory Challenges in Asia
Gina Brackett, Phil Pontikos, Ben Dastoli, & Laureen Geniusz FDA Investigator Insights