September 2005
Volume 9, Number 9
  Working to make Massachusetts the medical device capital of the world

Proven Process Medical Devices-Results Built In, sponsor of MassMEDIC News

 

MassMEDIC Launches New Initiative Aimed at Developing Ties to Plastics Sector

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FDA Commissioner Crawford to Host Town Hall Meeting in Boston

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MassMEDIC Welcomes New Members


Fall Program Calendar: MedTech Investors Conference and Sessions on Product Lifecycle Management, Boot Camp & FDA Wrap-up

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Special Interest Groups Address Hiring Requirements, IP Strategies, Fundraising

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MDMA Program Offers 510(k) Submission Assistance

Medical Device Manufacturers Association (MDMA)
presents

What Every Medical Technology Company Should Know about the 510(k) Process
A Workshop on FDA's Premarket Review of Medical Devices

September 30, 2005 – Mass. Hospital Association – Burlington, Mass.

Special Registration Rate for MassMEDIC Members!
Register Here

Click Here to View Agenda
Topics to be discussed:
FDA's Premarket Review of Medical Devices
Expedited Review
FDA's Third Party Review Program
Designing Your Study to Support a "Substantial Equivalence" Determination
Maximizing Your 510(k) - Life After Clearance
For more information, please contact Erin Jones - 202/349-7172 ejones@medicaldevices.org


Register Now for WPI’s Medical Device Certificate Program
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MassMEDIC to Sponsor OEM New England’s Medical Suppliers Pavilion


MassMEDIC Notes

Want an advance look at BU’s MBA candidates? The Entrepreneurial Management Institute at Boston University School of Management has assembled this year’s Entrepreneurship Concentration resume book and it is now available at no cost to potential employers. The students in this resume book are in BU’s MBA Program and have chosen to concentrate in Entrepreneurship and have expressed a strong interest in working for early stage and entrepreneurial companies. To obtain your copy , please contact Dan Beaudry at beaudrd@bu.edu or 617-353-9491. …. MicroTest Laboratories announced it has received a loan of $1.16M from MassDevelopment to expand its Agawam facility and add 50 jobs to its roster. The loan was distributed via MassDevelopment’s Emerging Technology Fund, which is designed to support the growth of high-tech companies in Massachusetts. To date, MassDevelopment has granted nearly $8.9M in loans to Bay State businesses. MedTech companies interested in the Emerging Technology Fund can contact MassDevelopment at 800.445.8030…. After recently declaring its plans to file for an IPO, Natick-based Neothermia Corporation announced it has received 510(k) clearance for expanded indications of its en-bloc® breast Biopsy System.


MassMEDIC gratefully acknowledges the support of its Premium and Sustaining Members.

Premium Members

Accellent

BD

Cambridge Consultants

Genzyme Corp.


Goodwin Procter, LLP

Haemonetics Corp.

Medtronic

Nova Biomedical Corp.

Philips Medical Systems

Smith & Nephew Endoscopy

TIAX LLC

Sustaining Members

ABIOMED, Inc.

ACMI

Adams Harkness, Inc.

Analogic Corporation

Arrow International, Inc.

Bayer Corporation

Boston Scientific Corporation

Brown Brothers Harriman & Co.

C.R. Bard, Inc.

Candela Corporation

Codman and Shurtleff, Inc. A Johnson & Johnson Company

Cytyc Corporation

D&R Products Company, Inc.

Deloitte & Touche LLP

Draeger Medical Systems, Inc.

Ernst & Young

Fish & Richardson P.C.

Foley, Hoag LLP

Grant Thornton LLP

Greenberg Traurig, LLP

Health Advances, Inc.

Hologic, Inc.

Kirkpatrick & Lockhart Nicholson Graham LLP

KPMG, LLP

LehmanMillet

LEK Consulting

Massachusetts Technology Collaborative


Medical Device Consultants, Inc.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Morrison Mahoney LLP

Nixon Peabody LLP

Nutter, McClennen & Fish, LLP

NYPRO, Inc.

Palmer & Dodge, LLP

PriceWaterhouseCoopers, LLP

Ropes & Gray

Schwartz Communications, Inc.

The Mullings Group

Wilmer Cutler Pickering Hale and Dorr LLP

Wolf Greenfield

ZOLL Medical Corporation



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