On January 19, 2011, the FDA announced a long awaited plan of action for implementation of steps to a smarter medical device program (click here to read more about this plan). New Guidances, as well as the Institute of Medicine’s Report, are expected this summer.
This morning, The Southern New England Entrepreneurs Forum ("SNEEF") hosted its FDA Medical Device Update at the UMass / Dartmouth Advanced Technology & Manufacturing Center, where industry experts discussed the implementation of the plan, as well as other emerging issues and reaction from the investment community.
The following is of list of the speakers, including a link to .pdf versions of their respective slide presentations (as available):
Moderator: Robert J. Kerwin, Esq., Tarlow, Breed, Hart & Rodgers, P.C.
Panelists:
Marguerite Piret, President & CEO - Newbury Piret & Co.
Piret Presentation.pdf
Barry Sands, President - RQMIS, Inc.
Sands Presentation.pdf
Mutahar S. Shamsi, District Director - U.S. Food & Drug Administration
Shamsi Presentation.pdf
Thomas J. Sommer, President - MassMEDIC
Casper Uldriks, Esq. - Olsson Frank Weeda Terman Bode Matz, PC
Uldriks Presentation.pdf
Diana Upton, President - IAMERS
Upton Presentation.pdf
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