Crimson Solves Japanese Translation Dilemma for U.S. Medical Device Manufacturers

Tokyo-Based Production and Advanced Technology Provides Welcome Relief

Tokyo, Japan, April 28, 2011 
Crimson Life Sciences, a division of TransPerfect and the world’s only
ISO 13485 and ISO 14971-certified translation provider, today announced the opening of a dedicated
production facility in Tokyo, Japan. Utilizing TransPerfect’s proprietary GlobalLink™ Translation and
Review Portal, Crimson Japan provides a solution for manufacturers who are struggling with translation
issues in the challenging Japanese market.
Lost in Translation
Between the age of 25 and 65, medical device consumption increases, on average, by 500%. With the
world’s most rapidly-aging population, Japan is an established and growing market for device
manufacturers. Regulatory changes now make it easier for US companies to serve this market directly,
without losing control or profit through distributors.
However, the challenges of into-Japanese translation can present a significant obstacle to US
manufacturers. The Japanese language itself is unique – an “isolate” unrelated to any other language in
the world. The subtleties of linguistic style, formality, and context are so challenging to master that nativeborn Japanese citizens who live outside of Japan for more than five years are often no longer considered “native speakers” by their in-country compatriots. The significant differences in translation  style between regulatory documents and marketing material, combined with the stringent quality expectations of a Japanese audience, can lead to frustration for manufacturers.
According to Crimson President Marc H. Miller, “Many manufacturers have communications challenges
with their Japanese subsidiaries. In some cases, these issues have become so acute that parent
companies have dismissed their entire Japanese staff. Of course, communications problems of any type
can lead to delayed product submissions and approvals or lost sales and revenue.”
Japanese Medical Device Translation: an Inside Job
To overcome the challenges associated with Japanese translation, an in-country production presence is
required. Explains Miller: “If you work with a US-based translation provider without a production presence in Japan, then specific regulatory requirements and nuanced marketing language can be as mysterious as the sphinx.” In other words, without in-country, native-speaking translation and QA resources who are specifically tested for each particular type of content, manufacturers may never resolve the problems presented by Japanese regulatory and marketing translation.
Advanced Technology Eases Review Burden
Faced with these challenges, many manufacturers rely on in-country review by Japanese-speaking staff
or distributors to ensure quality. However, problems associated with translation review – including review format and subjective or inconsistent comments – can add confusion and delay. Quips Miller, “Translation review is rarely a panacea…and particularly with Japanese, the cure is often worse than the disease.”
In order to address the problem of Japanese translation review, Crimson draws upon its relationship to
parent company TransPerfect and its advanced Translation and Review Portal (TRP) — part of the
GlobalLink suite of translation productivity tools. The web-based TRP tool provides reviewers with a
structured, intuitive environment for review of translated material. TRP also provides a “preview” function so that reviewers can see the translated material in context—a key requirement for the nuanced demands of Japanese translation. ROI calculations that take into account the total cost of review (including reviewer time, verification of changes, implementation of changes, etc.) demonstrate an immediate, substantial payoff.
“Thank You for Solving Our Japanese Problem”
Crimson’s Tokyo office provides manufacturers with access to specialized, native-speaking resources for
successful regulatory submissions and fluent marketing collateral. These resources, combined with
TransPerfect’s GlobalLink™ TRP technology create an unmatched system for effectively producing highquality into-Japanese translations that are readily accepted by both Japanese colleagues and clients. In fact, the results of this comprehensive approach prompted one Senior RA/QA executive from a global device manufacturer to comment, “I want to thank you for solving our Japanese problem.”
About Crimson Life Sciences
Crimson is a division of TransPerfect Translations International, Inc. and is the only translation practice
devoted exclusively to high-risk medical devices and IVDs. Crimson is the world’s first translation firm
registered to ISO 13485 and ISO 9001 and the only translation firm registered to ISO 14971.
TransPerfect, registered to ISO 9001 and EN 15038, is the world’s largest privately held language
services provider with more than 60 offices worldwide.




Crimson Life Sciences has become
TransPerfect Medical Device Solutions.

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