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ISO 14971-CERTIFIED RISK MANAGEMENT SYSTEM YIELDS FIRST LABELING TRANSLATION PATENT

BOSTON, MA, February 19, 2008 – Crimson Life Sciences (a division of TransPerfect Translations) today announced that it has filed the industry’s first patent for "analyzing, evaluating, and controlling risk of language errors in connection with medical device labeling." Based on the first ISO 14971-certified risk management system, the filing effectively establishes GMP for labeling translation. The official patent filing provides excellent guidance for translation supplier audits—requests for copies can be sent to: mmiller@crimsonlanguage.com.

First Certified Risk Management System is Basis for
Groundbreaking Labeling Translation Patent

On January 31, 2008, Crimson Life Sciences filed the medical device industry's first-ever risk management patent for labeling translation. The official application, Method of Managing Error Risk in Language Translation, specifically addresses "methods for analyzing, evaluating, and controlling risk of language translation errors in connection with medical device labeling.

The pending patent is based on the first-ever ISO 14971-certified translation risk management system. Crimson's risk management system was certified by Underwriters Laboratories (UL) as part of its newly-introduced ISO 14971 audit services. The company's certification audit was conducted by Dr. Harvey Rudolph, an original co-author of the standard and co-Chair of the US Technical Advisory Group on Risk Management.

Prior to the formal filing, Crimson had an informal, provisional application with the USPTO. However, in August 2007, Crimson became the first company to successfully certify a risk management system to ISO 14971:2000 (risk management standard for medical device manufacturers and suppliers). Explains Crimson’s President, Marc Miller, “Our valuable work with Dr. Rudolph and ISO 14971 provided the development push we needed to complete Crimson’s formal risk management system and the formal patent application process.”

Kai Simonsen, Crimson’s VP of Production & Quality Systems and chief architect of the risk management system and patent agrees, “The basic components were clearly present in our provisional filing. Bringing the system into formal compliance with ISO 14971 required us to tie the system together as a unified whole—and this was exactly what was needed to complete the formal patent application.”

Patent-Pending Process Establishes GMP for Labeling Translation

In an official report, Dr. Rudolph highlights the importance of labeling translation:

“Generating accurate translations... helps to assure that devices are operated safely. This is especially true for those portions of the labeling that are themselves risk controls established by the manufacture. Also, there is no doubt that failures of labeling translation comprise post-market information that the... manufacturer needs to assess as part of its risk management process.”

The importance of supplier risk management for translated labeling is underscored by KEMA Notified Body: “Notified Bodies consider translation to be an ‘important outsourced service.’ ... This makes translation providers subject to the outsourced vendor risk management considerations of ISO 13485:2003 and ISO 14971.

By adopting an innovative, risk management approach, Crimson has established the de facto process standard for labeling translation quality. Explains Simonsen, “Labeling translation is a professional service that carries a significant risk of human error. Since translation error risk cannot be completely eliminated, it must be managed.” Crimson’s patent-pending process includes a proprietary QA step, BackEditing™—the only translation risk management method to receive an official Notified Body endorsement.

Notes Simonsen, “Our internal audits demonstrate that BackEditing reduces the risk of serious translation error by over 60%.” Crimson practices the only Notified Body-approved method of translation audit.

Patent is Basis for Innovative Risk Management Services

Crimson’s patent-pending methods form the basis for many labeling risk management services:

  • Eliminate Distributor Review – A Notified Body-approved methodology for elimination of full-document overseas review.
  • Audit of Translated Labeling –  The only Notified Body-approved method for audit of translated labeling.
  • Validation of Translated Labeling – Crimson is qualified to serve as a third-party validator for high volume engagements. Crimson serves in this vital QA role for several manufacturers of large scale, capital devices.
  • Validation of Translated Software – Translated versions of software user interface requires documented validation. Crimson’s risk-based approach to medical device software validation has been published by AAMI’s BI&T Journal
  • Outsourced Labeling Solutions –  Based on Crimson’s risk management credentials, the firm has been qualified by major manufacturers to fulfill critical labeling requirements, such as updates, as an outsourced suppler. This service frees internal resources to focus on new product development and other high-value activities.

PATENT APPLICATION PROVIDES IMPORTANT AUDIT GUIDANCE

The revised version of the MDD explicitly confirms existing regulatory guidance: device manufacturers are responsible for their outsourced processes—including labeling, labeling translation, and product information.

In the light of the increased use of third Parties to carry out the design and manufacture of devices on behalf of the manufacturer, it is important that the manufacturer demonstrates that he applies adequate controls to the third party to continue to ensure the efficient operating of the quality system.
 — Official Journal of the European Union (2007-11-05); item 21

Since Notified Bodies classify labeling translation an “important outsourced service,” appropriate control is crucial under the MDD’s expanded requirements. Crimson’s patent document provides valuable guidance for manufacturers seeking to understand and apply current best practices to qualification and audit of their labeling translation suppliers. The official filing materials are available to manufacturers by sending a request to: mmiller@crimsonlanguage.com.

VALUABLE MDD, IVDD, ISO, AND OTHER REGULATORY RESOURCES ONLINE

The Crimson website is a valuable source for regulatory guidance and materials. For instance, Crimson maintains the industry’s only publicly available IFU Symbols Library (350 electronic labeling symbols), plus a complimentary version of Ed Kimmelman’s “Quality Systems Matrix” (correspondence between ISO 9001:2000, ISO 13485:2003, and 21CFR). This is the same fee-based information sold by AdvaMed. All items require a password. Requests for access password should be emailed to: mmiller@crimsonlanguage.com

About Crimson Life Sciences
Crimson Life Sciences, founded in 1992, is the only translation practice exclusively dedicated to the needs of the medical device industry. Crimson is the only translation organization in the world to hold ISO 9001:2000 and ISO 13485:2003 certifications. Crimson was the first company to register to ISO 14971 through UL’s newly-introduced audit service. Crimson's registered risk management system is the basis for the industry's only patent pending for labeling risk management. Crimson clients include industry leaders such as Cook, Stryker, Chiron, Bio-Rad, and Arrow International.

In 2005, Crimson merged with TransPerfect Translations (world’s third-largest language service provider), to form the industry’s premier life sciences practice. Clients enjoy access to the expanded process and technology resources of the entire TransPerfect family of companies, including software localization specialist, Translations.com. More information is available at the Crimson website: http://www.crimsonlanguage.com.

Crimson’s original founder, Marc H. Miller, continues to provide management guidance as division President. Miller received a BA in languages and literature from Harvard University and an MBA from the Scottish Business School in Stirling, Scotland. While working as a Senior Research Fellow with the international strategy consulting firm of SIAR, he authored strategic assessments for European and US medical technology firms. Crimson’s specialized approach to medical technology translation has also been featured in industry publications such as Medical Device & Diagnostics Industry, Medical Products Outsourcing, and Orthopedic Design & Technology.

For publications and resources, please visit:

http://www.crimsonlanguage.com

For further information, please contact:
Marc H. Miller
President
Crimson Life Sciences
167 Corey Rd., Ste 100
Boston, MA 02135, USA
p +1 617.731.6920
f +1 800.798.9673
mmiller@crimsonlanguage.com
http://www.crimsonlanguage.com

 

 

 
 
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