Past MedCon Presentations

For your convenience the presentations and other materials from past MedCon conferences have been loaded onto this page.
Speakers Session Title Presentation
Thinh Nguyen & John "Barr" Weiner MedCon 2015: Update from FDA’s Office of Combination Products
Jeff Shuren MedCon 2015: Center Director Corner: Strategic Priorities for 2015 and Beyond
Jan Welch MedCon 2015: Office of Compliance Strategic Priorities
Francis Blacha, Marian Lee, Bob Banta, Bradley Thompson, & Spencer Timmel MedCon 2015: Advancements in Medical Device Software Technology
Kim Trautman, Scott Sardeson, & Bill Brodbeck MedCon 2015: Understanding & Preparing for the Revision of ISO13485
Jay Crowley MedCon 2015: UDI – Implementation “Ain’t” Easy
Monica Wilkins, Susan Rolih, Cynthia Ipach, & Steve Niedelman MedCon 2015: FDA 483 Observations: What to Do and How to Do It
Paul Brooks & John Brennan MedCon 2015: EU Medical Device/IVD Regulation Review
Kim Trautman MedCon 2015: Understanding the Current Activities of the International Medical Device Regulators Forum (IMDRF)
Bill Maisel MedCon 2015: Update from the Office of Device Evaluation
Monica Wilkins, Steve Niedelman, Phil Pontikos, Gina Brackett, & Bill Brodbeck MedCon 2015: Complaints, CAPAs, Recalls – What to Do and When
Barbara Zimmerman & Quynh Hoang MedCon 2015: Increase Speed to Market with an Effective Regulatory Strategy
Marjorie Shulman MedCon 2015: Improving your Chance of 510(k) Success
Evangeline Loh MedCon 2015: Understanding the Regulatory Challenges in Asia
Gina Brackett, Phil Pontikos, Ben Dastoli, & Laureen Geniusz MedCon 2015: FDA Investigator Insights
Paul Brooks MedCon 2014: EU Regulations: New Regulations, Company Strategy and Open Discussion
Steve Silverman MedCon 2014: Office of Compliance Update
Jay Crowley and Steve Niedelman MedCon 2014: How to Implement the UDI Requirements
Lawrence "Jake" Romanell and Mark Heller MedCon 2014: Managing Scientific and Regulatory Disagreement
Patrick Caines, Rebecca Hoffman, and Gina Brackett MedCon 2014: Operationalizing Post-Market Surveillance
Marian Lee and Kyle Peterson MedCon 2014: FDA Regulation of Health Information Technology
Julie Aker MedCon2014: Understanding Changes to Patient Labeling Requirements
Susan Rolih, Dennis Hahn, Lenore Faulhaber, Monica Wilkins, Steve Binion, and Nancy Singer MedCon 2014: Changing Perceptions-Moving from Necessary Evil to a Strategic Partner
Thinh Nguyen and John "Barr" Weiner MedCon 2014: What to Expect in 2014 with Combination Products
Christy Foreman MedCon 2014: Updates from ODE Leadership
Pat Baird and Francis Blacha MedCon 2014: Implementing Effective Risk Management Programs
Christy Foreman MedCon 2014: Increasing the Integrity and Efficiency of the 510(k) Process
Thinh Nguyen, John Weiner, Suzanne O'Shea, and Francis Blacha MedCon 2014: Combination Products Working Session
Jennifer Goode and David Eaker MedCon 2014: Impact of the Changes to the FDA Biocompatibility Guidance
Gina Brackett, Marla Phillips, Monica Wilkins, and Joe Pinto MedCon 2014: Purchasing Controls--"How to"
David Eaker, Heather Rosecrans, Susan Rolih MedCon 2014: Successfully Navigating the Pre-Sub Process
Landon Lack MedCon 2014: Strategic Thinking on Access in China
Mark Parmon, Merril Racke, and Dennis Hahn MedCon 2014: Understanding and Addressing the Challenges of Import
Gina Brackett, Laureen Geniusz, and Ben Dastoli MedCon 2014: FDA Investigator Insights
Ginger Swassing MedCon 2013: Industry Reaction to New EU Regulations
Jeff Shuren MedCon 2013: FDA Update
Steve Silverman MedCon 2013: The Case for Quality
Steve Niedelman and Jim O'Reilly MedCon 2013: FDA Safety and Innovation Act
Jay Crowley MedCon 2013: Unique Device Identification
Christy Foreman MedCon 2013: ODE Update
Christy Foreman MedCon 2013: Pre-Submission Program and Meetings with FDA
Mark Duval and Phil Phillips MedCon 2013: 510 (k) Delays
Mariam Lee MedCon 2013: Healthcare on the Go
Thinh Nguyen, John "Barr" Weiner, and Winifred Wu MedCon 2013: Combination Products
Suzanne Halliday MedCon 2013: How to Get a Product into the European Market
Suzanne Halliday MedCon 2013: CE Mark Hot Topics--Risk vs. Benefits
Gina Brackett and Maria Cianciotto MedCon2013: The CAPA Process
Susan Alpert MedCon 2013: Global Product Strategy
Ann Marie Boullie MedCon 2013: Success in Central and South America
Gina Brackett, Laureen Geniusz, Phil Pontikos, Ben Dastoli MedCon 2013: FDA Investigator Insights
Gert Bos MedCon 2012: EU Regulations Update and Impact
Christy Foreman MedCon 2012: ODE Perspective
Kim Trautman MedCon 2012: New International Medical Devices Regulators Forum (IMDRF) and FDA Bilateral Initiatives
Kim Trautman and Steve Niedelman MedCon 2012: The Purchasing Control Subsystem--Requirements and Implementation
Dennis Hahn, Phil Phillips, Christy Foreman MedCon 2012: Draft 510 (k) Guidance-Deciding When to Submit a 510 (k) for a Change or Modification
Kim Trautman MedCon 2012: ISO 13485 Voluntary Audit Report Submission Pilot Program
Steve Silverman MedCon 2012: FDA 483s and Regulatory Action Response Workshop
Gert Bos and Rita Hoffman MedCon 2012: Recals--Globally
Gina Brackett and Maria Cianciotto MedCon 2012: GHTF Document on CAPA Workshop
Mark Duval, David Cannistraci, Dennis Hahn, Phil Phillips, Winifred Wu MedCon 2012: 510(k)--An Industry Perspective
Phil Pontikos and Monica Wilkins MedCon 2012: Interdependency of Post-Market Surveillance, Risk, and CAPA
Ed Basile MedCon 2012: Promotional Practices--Global
Steve Silverman MedCon 2012: FDA Inspection Trends and Office of Compliance Initiatives
Julius Aviza and Phil Pontikos MedCon 2012: Risk Management Across the Quality Systems--Demystified
Cecilia Kimberlin MedCon 2012: Global Regulatory Strategy
Gina Brackett, Laureen Geniusz, Ben Dastoli, Phil Pontikos MedCon 2012: FDA Inspectional Approach