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MAY 13-14: sYMPOSIUM
The Florida Medical Device Symposium is Florida's premier event for medical device manufacturers and allied industries, featuring nationally recognized speakers, expert panels on regulatory issues and industry trends, exhibiting companies, legislative updates and quality networking opportunities.
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Attendee Pricing
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Symposium Attendee Badges:
FMMC Members: $329
Non-Members: $479
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FMMC Member Special:
Symposium Only (33% Discount)
"3 Attendees for Price of 2" - $658
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Symposium + Workshop Package
FMMC Members: $398
Non-Members: $558
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FMMC Member Special:
Symposium + Workshop Package
"3 Attendees for Price of 2" - $856
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Room Block Ends 4/30
Room Rate: $173
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symposium Speaker Highlights
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Blake Bevill
Division Director
Office of Medical Device &
Radiological Health Ops (Div 2)
U.S. Food & Drug Admin (FDA)
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Melissa Michurski
Director of Compliance
Office of Medical Device &
Radiological Health Ops (Div 2)
U.S. Food & Drug Admin (FDA)
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Joshua Silvestri, CSO
Investigator/Device Specialist
Office of Medical Device &
Radiological Health Ops (Div 2)
U.S. Food & Drug Admin (FDA)
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Mark Leahey
President & CEO
Medical Device Manufacturers
Association (MDMA)
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Dr. Christopher McCarty
Director, Bureau of Economic
and Business Research (BEBR)
University of Florida
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Anthony S. Freeman
President
A.S. Freeman Advisors, LLC
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Lisa Michels J.D., M.S.O.L.Q
General Counsel & Regulatory Affairs Expert, Regulatory Compliance Associates (RCA)
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Erin Wright
Validation Product Manager
MasterControl
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May 14: Special biocompatibility Workshop (2pm)
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Nicholas Christiano
Senior Manager
E&L Medical Devices
Nelson Laboratories
Registration ($99)
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Biocompatibility Compliance, ISO 10993 & MDR: How to Address New Regulatory Changes that Impact Medical Device Manufacturers
This session will examine the shifting regulatory landscape for medical device biocompatibility that is evolving with the new release of the EU's Medical Device Regulation (MDR) and the recent updates to the ISO 10993 suite of standards including 10993-1, 10993-18 and those to follow. After May 2022, all devices sold in the European market will have to demonstrate compliance with ISO 10993, even if the device has been on the market for years. These recent regulatory changes and those in the pipeline need to be evaluated within the context of an existing biocompatibility program. In this workshop, you will learn how to evaluate your biocompatibility information and determine what the gaps are and your options in addressing them. This presentation will also walk through a real-life example of bringing a device that has been on the market in Europe into compliance with the ISO 10993 and the new MDR.
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