2012 Schedule

WEDNESDAY, MARCH 21, 2012

Welcome Remarks
Carol Herman, AAMI
Eamonn Hoxey, PhD, BPharm, FRPharmS, Johnson & Johnson

Applying Quality Systems to MDDS Requirements
John Murray, MS, CSQE, U.S. Food and Drug Administration
Rick Hampton, Partners HealthCare Systems

Medical Device Interoperability: What the Future Holds for Standards
Geoff Pascoe, MSCCS, BEE, GSEC, Consultant
Bakul Patel, MSEE, MBA, U.S. Food and Drug Administration

510k Processes: An Update from the FDA
Joni Foy, PhD, U.S. Food and Drug Administration

The International Medical Device Regulators Forum (IMDRF, formerly GHTF): Its Role and Direction
Kimberly Trautman, U.S. Food and Drug Administration

Application of Standards for Combination Products
Joe Lewelling, AAMI
Thinh Nguyen, U.S. Food and Drug Administration
Stephanie Del Paine, PhD, MED Institute, Inc.

Device Clock Synchronization Challenges: What Does It Mean for Medical Devices? 
Julian M. Goldman, MD, Massachusetts General Hospital, Partners HealthCare System, and CIMIT (Moderator)
Kevin Brady, National Institute of Standards and Technology
James Fackler, MD, The Johns Hopkins University School of Medicine
Ken Fuchs, Mindray North America

How to Test to IEC 60601-1, 3rd Edition
Joe Murnane, BSEE, Underwriters Laboratory, Inc.
Frank O'Brien, BSEE, MS, O'Brien Compliance Management, LLC
Brodie Pedersen, Nonin Medical

FDA Human Factors Draft Guidance Document: Agency Expectations for Human Factors Data in Premarket Submissions
Molly Story, PhD, U.S. Food and Drug Administration

From Summits to Action Plans: A Progress Report on Projects for Infusion Systems, Alarms and Medical Device Reprocessing
Leah Lough, AAMI

Insights on the European Standards Scheme and the Impact that Recent Standards Activities in Europe Will Have on Your Company
Eamonn Hoxey, PhD, BPharm, FRPharmS, Johnson & Johnson
Paul Brooks, British Standards Institute, Inc.
Andy Vaughan, Association of British Healthcare Industries, Ltd.

What Does Sustainability Mean for the Medical Device Industry?
Cliff Bernier, AAMI
Suzanne Fiorino, MBA, Johnson & Johnson – Medical Device & Diagnostics
John J. Garguilo, National Institute of Standards & Technology

Richard Cook, MD, University of Chicago

Requirements and Challenges in Designing and Maintaining Standalone Software
Rick Chapman, MS, U.S. Food and Drug Administration
Geoff Pascoe, MCCS, BEE, GSEC, Consultant

Addressing the Challenges with Medical Device Cyber Security
Nathanael Paul, PhD, Oak Ridge National Laboratory/University of Tennessee
Axel Wirth, Symantec Corporation