Crimson Introduces "Expert Opinion" Webinar Series
Senior Quintiles Consultant Presents at Inaugural Event
Boston - June 9, 2009 -
Crimson Life Sciences, the specialized medical device division of global language and business services leader TransPerfect, today announced that June 9, 2009 will mark the premier of their “Expert Opinion” webinar series. Kicking off the first in this series of online educational events is Ms. Caroline Freeman, Senior Consultant with Quintiles.
The Practitioner’s Perspective
The inspiration for the Expert Opinion webinar series 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 approach—and often, this is something that can be best learned from conversations with seasoned experts.” The title of the series is derived from the ISO 14971 standard itself, where “expert opinion” is cited as one valuable source for risk estimation.
Front and Center: Medical Device Labeling
Labeling and labeling translation – an issue of increasing importance for medical device manufacturers – is the subject of Crimson’s first online event. Recent studies show that the average error rate in translated medical device labeling is 400% higher than produced by current best practice. Regulatory authorities such as Underwriters Laboratories have issued guidance recommending ISO 13485 and ISO 14971 certification for labeling translation suppliers. Furthermore, EU Competent Authorities are now conducting studies on the readability and comprehensibility of instructions for use.
The subject of the inaugural webinar was a natural, considering Crimson is the only translation practice exclusively devoted to medical device labeling. The choice of Caroline Freeman as presenter was equally relevant. Says Miller, “In 2008, I co-chaired a labeling translation workshop in Brussels with Caroline and was extremely impressed by her depth of knowledge and insight around labeling issues. Her senior position with Quintiles combined with 20 years of industry experience made her an ideal candidate to provide our first Expert Opinion.” Future Expert Opinion webinars will focus on key issues facing medical device manufacturers, with an emphasis on presenter’s depth of experience and value of information.
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.
