New Disclosure Laws for Medical Device Companies

Expert Opinion Webinar Focuses on Newly-Enacted Legislation

Boston - July 6, 2009 

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. 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. 

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.

 

 

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TransPerfect Medical Device Solutions.


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