Florida Medical Device Symposium

The 2019 Florida Medical Device Symposium will provide your company with excellent exposure and access to hundreds of medical device professionals and decision-makers over the two-day event.  By being a sponsor at the Florida Medical Device Symposium, you will not only gain exposure at the conference, you will also receive special benefits available only to sponsors. Benefits range from promotion of your company, brand recognition, acknowledgement in the conference program and much more. Below is a listing of the sponsorship levels and their associated benefits.

MON|MAY 13    
10:00 - 1:00 Registration/Exhibitor Set-up  
1:00 - 1:10 Welcome & Opening Remarks

Jim Jones, Chair, FMMC Symposium Committee

John Ray, Executive Director, FMMC

FDA "Super Session"

Hear from and network with key FDA officials and staff who lead all medical device inspectional and compliance activities covering eighteen (18) states from Florida to Minnesota. This interactive FDA session will cover a myriad of compliance and regulatory issues critical to the medtech industry, as well as Q&A and discussion.

1:10 - 1:30

Updates on Key FDA Priorities & Initiatives

Topics include Program Alignment, FDARA, Transparency, Nonbinding Form 483 Feedback, Experiential Learning and Regulatory Convergence/ISO

Blake Bevill, Division Director, Office of Medical Device and Radiological Health Operations (OMDRHO/Division 2), U.S. Food & Drug Administration
1:30 - 3:00

FDA-Industry Panel: Hot Topics

  • Device Inspectional Issues
  • Top 483 Observations and Recent Trends
  • cGMP/QSIT Compliance Issues
  • Unique Device Identification (UDI)
  • MDSAP
  • Device Recalls

Melissa Michurski
Director of Compliance OMDRHO/Division 2, FDA (Minneapolis, MN)

Joshua Silvestri, CSO,

Investigator/Device Specialist

U.S. Food & Drug Administration
(Maitland, FL) 

Neisa Alonso, Recall Coordinator, FDA (Maitland, FL)

 

Jeffrey Shapiro, Director Hyman, Phelps & McNamara, P.C.

3:00 - 3:30 Refreshment Break with Exhibitors  
3:30 - 4:15 Washington Review: Comprehensive Update on Issues Facing the Medical Device Industry in the 116th Congress
Mark Leahey, President & CEO, Medical Device Manufacturers Association (MDMA) 

4:15 - 5:15

Global Trends in the Medical Device Industry and Supply Chain

Anthony S. Freeman
President

A.S. Freeman Advisors, LLC

5:30 - 8:30

Opening Night Reception & Exhibit Hall Grand Opening

Join us for cocktails, hors d’oeuvres, networking, exhibits and live music.

Picasso DEF/Patio
TUES|MAY 14    
7:30 - 9:00 Full Breakfast Buffet with Exhibitors Picasso DEF
9:00 - 9:50 What’s New with 510(k)s?

Lisa Michels J.D., M.S.O.L.Q
General Counsel & Regulatory Affairs Expert, Regulatory Compliance Associates (RCA)

Valerie Followell

President

Followell Compliance Consultants

9:50 - 11:00 Industry 4.0/5.0: How Robotics, Advanced Automation, and Machine Learning Are Changing the Face of MedTech Manufacturing

Panel Session

11:00 - 11:30 Refreshment Break with Exhibitors  
11:30- 12:30

Software Validation: Practical Approaches to Achieve Compliance While Saving Time and Resources

Medical device firms are required to validate “electronic systems” that create, modify, maintain, archive, retrieve, or transmit electronic records. But the challenge is while FDA regulations and international  standards require software validation, they do not specify how companies should go about the validation process. This session will explore the common validation problems encountered by regulated companies. And our speaker will cover what you need to know to validate your medical device software to meet FDA’s expectations and how to prove to FDA that you validated your software properly and successfully.

Erin Wright

Validation Product Manager MasterControl

12:30 - 1:45

Keynote Luncheon

Florida’s Economy: Healthy or Ailing?

Christopher McCarty

Director, Bureau of Economic and Business Research (BEBR) and Associate Dean, College of Liberal Arts and Sciences,

University of Florida

2:00 - 5:00

Special Workshop*

*Additional Registration Required ($99)

*Symposium + Workshop Package Discounts Available

Biocompatibility Compliance: How to Address New Regulatory Changes that Impact Medical Devices
This special 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. 
Nicholas J. Christiano, M.S., M.B.A. 
Senior Manager - E&L Medical Devices
Nelson Laboratories, LLC
5:00 - 5:05 Closing Remarks & Adjourn Geary Havran, Chairman, FMMC
     

**Times and topics subject to change

Event Properties

Event Date 05-13-2019
Event End Date 05-14-2019
Location Hilton Carillon Park
Attachment symposium_sponsorships_-_201.pdf

Venue Information - Hilton Carillon Park

FMMC
info@floridamedtech.com
850-270-3158

Speakers

Blake Bevill

Division Director

Blake Bevill Division Director Office of Medical Device & Radiological Health Ops (Div 2) U.S. Food & Drug Admin (FDA)

Melissa Michurski

Director of Compliance

Melissa Michurski Director of Compliance Office of Medical Device & Radiological Health Ops (Div 2) U.S. Food & Drug Admin (FDA)

Joshua Silvestri, CSO

Investigator/Device Specialist

Joshua Silvestri, CSO Investigator/Device Specialist Office of Medical Device & Radiological Health Ops (Div 2) U.S. Food & Drug Admin (FDA)

Mark Leahey

President & CEO

Mark Leahey President & CEO Medical Device Manufacturers Association (MDMA)

Dr. Christopher McCarty

Director, Bureau of Economic

Dr. Christopher McCarty Director, Bureau of Economic and Business Research (BEBR) University of Florida

Anthony S. Freeman

President

Anthony S. Freeman President A.S. Freeman Advisors, LLC

Lisa Michels J.D., M.S.O.L.Q

General Counsel & Regulatory

Lisa Michels J.D., M.S.O.L.Q General Counsel & Regulatory Affairs Expert, Regulatory Compliance Associates (RCA)

Erin Wright

Validation Product Manager

Erin Wright Validation Product Manager MasterControl

Nicholas Christiano

Senior Manager

Biocompatibility Compliance, ISO 10993 & MDR

Sponsors

We are no longer accepting registration for this event

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