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Symposium Presentations - 2017
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10:00 - 1:00 Registration/Exhibitor Set-up
1:00 - 1:05 Welcome & Opening Remarks

Geary Havran, Charman, FMMC


Jim Jones, Chair, FMMC Symposium Committee

1:05 - 2:15 Get “Audit Ready”…for FDA, ISO, Customer and Unannounced Audits
The seemingly-endless stream of audits and inspections med-tech manufacturers must endure can be dizzying, frustrating and perilous. From FDA inspections to unannounced audits, your company and employees must be prepared and knowledgeable on how to plan for, conduct and respond to an audit under various scenarios. What should my company do prior to an audit? How should I receive an inspector and what are my "rights"? What should I do or not do during an inspection? What should I say or not say? How and when should I respond to the audit findings?

Our panel of experts will explore these and many other questions, issues and best practices in getting "audit ready" and successfully navigating the sometimes long and unpredictable audit process.

Christine Cook
Vice President QA/RA
ProMedic, LLC


Aaron Dement

VP, Global Quality Assurance



Tim Wells

President, QualityHub, Inc.


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


   Shapiro Part 2

2:15 - 3:00 The New Medtech “Value” Proposition
New payment and care delivery models are driving hospitals, physicians, and payers to think
differently about patient care and focus on value. Providers are increasingly looking for ways to improve quality and outcomes, while at the same time, reduce costs. This session will explore the new paradigm and mandate on healthcare “value” and how it is impacting the purchasing practices of providers and the bottom-line of med-tech manufacturers.
Don May, Executive Vice President, Payment and Healthcare Delivery, Advanced Medical Technology Association (AdvaMed)
3:00 - 3:30 Refreshment Break with Exhibitors
3:30 - 4:15 Capital Review: Issues Facing the Medical Device Industry in Washington Clayton Hall, VP for Government Affairs, Medical Device Manufacturers Association (MDMA)
4:15 - 5:15

Keynote Session:

How to Lead, Manage and Weather Change

This interactive keynote is designed to help MedTech executives and managers take a renewed look at how to maximize business growth around three present realities: collaboration, talent development, and personal perspective.

Barry BantherCMC, CSP

President & CEO

Banther Consulting

5:30 - 8:30

Opening Night Reception & Exhibit Hall Grand Opening

Join us for cocktails, hors d’oeuvres, networking, exhibits and an evening capped off with live music under the beautiful Florida weather.

Picasso DEF/Patio
7:30 - 9:00 Full Breakfast Buffet with Exhibitors
9:00 - 9:45 MDSAP is Coming! – Taking Advantage of the Medical Devices Single Audit Program
Full implementation of MDSAP is underway, and this “single audit” pathway will assume increasing importance if you sell devices in the following markets: Canada, USA, Brazil, Japan or Australia. Health Canada has already announced that it will only accept MDSAP certificates starting on January 1, 2019. This session will share the most up-to-date information on the MDSAP program structure, benefits and implementation, as well as real industry experiences in using it.

Bernadette Low, Senior Quality Systems Manager, Guidant/Abbott Vascular


Tony Rizzo
AVP Healthcare Business Development, BSI


Mary L. McCoy

Prism Plus Consulting, LLC

9:45 - 10:45 Getting Started Selling into the Chinese Medtech Market
This panel discussion will explore some of the basic strategic and tactical considerations for accessing Chinese medical device market, and will discuss some of the key issues, regulatory trends, and challenges U.S. medical technology companies face in China.

Niclas Mottus-Olsson, President, CellMark Medical


Anthony Mak, Director – New York, Hong Kong Trade Development Council


Justin Heyl,Solutions Business Development Director, UL

10:45 - 11:15 Refreshment Break with Exhibitors
11:15 - 12:15 510(k) Updates: When and How to Work with the FDA on Device Modifications
In addition to covering some of the basics and best practices of a 510(k) submission, this timely session will address some key considerations when deciding whether or not to submit a new 510(k) for a device change; the FDA's most recent guidance and thinking on device modifications; and documentation best practices for keeping your 510(k) files up-to-date and FDA-compliant.

Heather Rosecrans
EVP, Medical Devices & Combination Products,
Greenleaf Health &VP of Regulatory Affairs, MDMA


Jan Flegeau,Director of Global Regulatory Affairs at E.M.M.A. Int'l Consulting Group; and Regulatory Affairs Manager for Sterilmed, a division of Johnson & Johnson (moderator)

12:15 - 1:30

Keynote Luncheon:

An Economic Forecast in Today’s Changing Political Climate

Sean M. Snaith, Ph.D.
Director, Institute for Economic Competitiveness
University of Central Florida

1:40 - 2:30 Managing Workplace Safety to Reduce Costs and Increase Productivity
This session will cover some key guidelines and workplace initiatives for developing and implementing a safety management system and culture in your facility, and will explore the relationship of your safety system and track record to managing Workers’ Compensation costs.

Risk Management Consultant

2:30 - 3:20

European Changes Affecting Medical Device Manufactures: Going from Directive to Regulation

The new European medical device regulations (MDR) and in vitro diagnostic regulations (IVDR) will come into force in May 2017, with full implementation deadlines now set for May 2020 and May 2022, respectively. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). Learn about major changes in the regulatory framework and ways in which device manufacturers are developing plans to meet these changes and to determine the impact on their business.

Tamas Borsai
Division Manager, Medical and Health Services
TÜV SÜD America Inc.
3:20 - 3:30 Closing Remarks & Adjourn Geary Havran, Chairman, FMMC
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