MedCon 2013 Videos & Presentations

You will gain many valuable insights at MedCon from thought leaders in the medical device industry. To help you use this knowledge in your organization, we post videos, PowerPoint presentations and summaries on this website shortly after the conclusion of the conference. All presentations will be available unless a presenter requests otherwise. 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 Matty Toomb, Associate Director, at 513-348-6141 or toombm@xavier.edu.
Speaker Title Videos Presentation Summary
Paul Brooks What’s New in the EU
Videos Presentation Summary
Ginger Swassing Industry Reaction to New EU Regulations
Videos Presentation Summary
Jeff Shuren (Remote) Keynote Address: FDA Update
Videos Presentation Summary
Steve Silverman The Case for Quality – Office of Compliance Update
Videos Presentation Summary
James O’Reilly, J.D.,
Steve Niedelman
FDA Safety and Innovation Act
Videos Presentation Presentation Summary
Jay Crowley Unique Device Identification
Videos Presentation Summary
Christy Foreman ODE Update
Videos Presentation Summary
Monica Wilkins,
Gina Brackett
Total Product Life Cycle
Videos Presentation Summary
Christy Foreman Pre-Submission Program and Meetings with FDA
Videos Presentation Summary
Phil Phillips,
Mark Duval
510(k) Delays: Is it FDA or Quality?
Videos Presentation Presentation Summary
Melissa Burns Update on New Guidances and Compliance Initiatives for PMA’s
Videos Presentation
Marian Lee Software and Mobile Apps
Presentation
Winifred C. Wu,
John Weiner,
Thinh Nguyen
Combination Products
Presentation Presentation Presentation
Suzanne Halliday How to Get a Product into the European Market: The ABC’s of CE Mark
Presentation
Suzanne Halliday CE Mark Hot Topics – Risk versus Benefits – EN ISO 14971, MedDev 2.7.1 / EN ISO 14155
Presentation
Susan Alpert, Ph.D., M.D. Global Product Strategy
Presentation Summary
Ann Marie Boullie Success in Central and South America
Presentation Summary
Phil Pontikos (Invited),
Laureen Geniusz,
Ben Dastoli,
Gina Brackett
FDA Investigator Insights
Presentation Presentation Summary