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2017 Annual Symposium
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May 8-9: The SYmposium

The 2017 Florida Medical Device Symposium will be held May 8-9, 2017, at the Hilton Carillon Park in St. Petersburg. The symposium is Florida's premier event for medical device manufacturing firms, featuring nationally recognized speakers, expert panels on regulatory issues and industry trends, legislative updates and quality networking opportunities. 


    

    

   


Attendee Pricing

Symposium Attendee Badges:
FMMC Members: $329
Non-Members: $479

FMMC Member Special:

3 Attendees for Price of 2 - $658

(33% Discount) 

 

May 10: Risk Management Workshop

ISO 14971 is the international standard for risk management for medical devices. It has become an essential element for satisfying regulatory requirements in most major markets and should be incorporated into the medical device life cycle. The standard requires medical device manufacturers to establish, document and maintain a risk management process to: 1) identify hazards and hazardous conditions; 2) estimate and evaluate the associated risks; 3) control those risks; and 4) continually monitor the effectiveness of the controls put in place. The concepts of ISO 14971 are applicable to a broad range of risks as is evidenced by its reference in numerous medical device standards, including but not limited to, the 3rd Edition of IEC 60601-1 (electrical safety), IEC 62366 (usability), ISO 13485 (quality) and IEC 62304 (software).

Presented by Underwriters Laboratories LLC, this seminar provides an overview of the fundamental concepts of Risk Management (RM) under ISO 14971 and the impact of Risk Management on medical/laboratory product safety evaluations. The session will discuss the influence of RM on a testing, product marking and accompanying documentation. The class will also explore how RM is used when deviating from requirements dictated in the safety standards (equivalent safety). Given the broad application of risk management, the seminar is particularly valuable to professionals working across the whole product lifecycle, including design, manufacturing, logistics, servicing and repair, product support and regulatory affairs.

Following a process allows one to create an RM file. Understanding its use and the impact of its contents will operationalize your Risk Management, thus allowing an organization to help navigate a path toward compliance and get the job done!

Instructor:  Gaspare Scaturro, Sr. Customer Solutions Consultant and Staff Engineer, Health Sciences
                    Underwriters Laboratories LLC


 

Workshop Date & Location

Wednesday, May 10, 2017

Hilton Carillon Park - St. Petersburg, FL

Gateway Room

8am - 2pm (breakfast & lunch included)

Workshop & Symposium Package Pricing

Workshop Only - $225

FMMC Symposium + Workshop (Member) - $415

FMMC Symposium + Workshop (Non-Member) - $565

Save up to 25% on Package Tickets


 


 

 

                 
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more Calendar

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