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MON|MAY 9    
10:00 - 1:00 Registration/Exhibitor Set-up  
1:00 - 1:15 Welcome & Opening Remarks Geary Havran, Charman, FMMC
1:15 - 1:30 State of the Florida's MedTech Industry John Ray, Executive Director, FMMC
1:30 - 2:45 New ISO 13485 Revisions (2016) - What's Changed and What's Important to Know?

Tamas Borsai, Division Manager of Non-Active Medical Devices, TUV SUD

 

Mick Howk, North American Product Manager, Medical Device Certification, SGS

 

Jan Flegeau
Regulatory Affairs Director
Oscor Inc. (moderator)

2:45 - 3:15 Refreshment Break with Exhibitors  
3:15 - 4:00 Washington Review: Issues Facing the Medical Device Industry in Congress Mark Leahey, President & CEO, MDMA
4:00 - 5:00 "Cognitive Computing and the Internet of Things - Unlocking the Data Challenge"

Kim Cobb

IBM Watson IoT

Global Industry Solution Exec

5:30 - 8:00 Opening Night Reception & Exhibit Hall Grand Opening
 
TUES|MAY 10    
7:30 - 8:30 Full Breakfast Buffet with Exhibitors  
8:30 - 9:30 Update on European Medical Device Regulation (MDR)
Paul Brooks, Senior Vice President Healthcare Solutions, BSI
9:30 - 10:30 The Evolving Landscape of Medtech Outsourcing: Implications for OEMs and Outsourced Service Providers

Ben Dunn
Managing Director
Covington Associates

 

Tom Black

VP Sales & Marketing

OEM and Int'l Divisions

B. Braun Medical Inc.

R. Reid Haney, Esq.
Hill Ward Henderson
(moderator)

10:30 - 11:00 Refreshment Break with Exhibitors  
11:00 - 11:45 FDA Compliance and Enforcement Issues and Trends within the Florida District

Susan Turcovski
Florida District Director
U.S. Food and Drug Administration (FDA)

11:45 - 12:15 Off-Label Promotion of Medical Devices

Jeffrey K. Shapiro

Director
Hyman, Phelps & McNamara

12:15 - 1:30

Keynote Luncheon - Adapt or Fail: Changing Business Models in Global Medtech

John Babitt, Americas Medical Technology Leader, EY
1:30 - 1:45 Mini Break  
1:45 - 2:45 Change Is Not an Option. Lessons in Lean Manufacturing and Continuous Improvement: A Customer's Perspective

Bill Thomas, Senior Manager
Supplier Performance Management, Honeywell

 

Carl Whitley, General Manger

R&D Machine & Engineering

2:45 - 3:00 Closing Remarks & Adjourn Geary Havran, Chairman, FMMC
WED | MAY 11     
8:00 - 5:00 Special Full-Day Sterilization Workshop:  
  Key Aspects of Radiation Sterilization for Medical Device, Pharmaceutical and Biotech Products

Kevin P.J. O’Hara, Director, Radiation Physics, Sterigenics

 

Niki Fidopiastis RM (NRM)
Director, Sterilization Consulting Group, Sterigenics

**Times and topics subject to change

 

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