"Dr. Disclosure" Webinar from Crimson Life Sciences Offers Expert Compliance Guidance

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Fri Jun 26, 2009 9:00am EDT

Fraudulent Study, New Disclosure Laws Mean Heightened Regulation and Risk for
Medical Device Manufacturers


BOSTON & SAN FRANCISCO--(Business Wire)--
Crimson Life Sciences, the specialized medical device division of global
language and business services leader TransPerfect, today announced the second
installment of their Expert Opinion webinar series. Scheduled for July 16, 2009
at 1:00 PM EDT, Crimson`s webinar is entitled "Dr. Disclosure: What the
Massachusetts Pharmaceutical and Medical Device Marketing Laws Mean for You" and
focuses on the newly-enacted pharmaceutical and medical device marketing
statutes in Massachusetts. Registration is offered free to manufacturers and
compliance professionals. The webinar features expert guidance from MassMEDIC
President Thomas Sommer, along with Pat Cerundolo and Colin Zick - partners with
the prominent Boston-based law firm of Foley Hoag LLP - who have been following
the development of the Massachusetts law and regulations and developing
strategies for device manufacturer compliance. Registration information is
available here. 

Expanded Regulation and Risk for Medical Device Manufacturers

Crimson`s "Dr. Disclosure" webinar provides a timely perspective. An $800,000
payment to an Army physician by device manufacturer Medtronic recently made
front page news. The physician is suspected of falsifying study data to support
the manufacturer`s product. 

Says Pat Cerundolo, partner with Foley Hoag, "Until recently, states have spared
medical device companies from reporting requirements. However, that is about to
change in Massachusetts." On July 1, 2009, Massachusetts will begin enforcing
what many feel is the most stringent legislation in the country. 

Adds Thomas Sommer, President of MassMEDIC, "Although quite burdensome for
manufacturers, many states are looking at the new Massachusetts law as a
model-it may well represent the shape of things to come for companies
nationwide." 

The Practitioner`s Perspective

The inspiration for Crimson`s Expert Opinion webinars comes from a series of
articles published in Medical Product Outsourcing magazine in 2008 by Crimson
President Marc H. Miller. Explains Miller, "Originally, the articles were
planned as a series of conversations with risk management experts. I`ve always
been a believer in the value of strategy-and often, this is something that can
be best learned from conversations with seasoned experts." The title of the
series is derived from ISO 14971, where "expert opinion" is cited as one
valuable source for risk estimation. 

About Crimson Life Sciences

Crimson is a division of TransPerfect Translations and is the world`s only
translation practice devoted exclusively to Class II and Class III medical
devices and List A and List B IVDs. Crimson is the first translation company
certified to ISO 13485 and ISO 14971. Crimson is also certified to ISO 9001 and
carries unique Notified Body endorsements for labeling translation risk
management. TransPerfect is the world`s largest privately held language services
provider with 56 offices worldwide. 



Crimson Life Sciences
Marc Miller +1 617.731.6920
mmiller@crimsonlanguage.com
www.crimsonlanguage.com

Copyright Business Wire 2009

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