Press Release

MEDICAL DEVICE FIRMS RECEIVE REGULATORY OK TO ELIMINATE TRANSLATED LABELING REVIEW

• Companies can reap significant savings by eliminating labeling review: Notified Body approves process
• Notified Body approves translation risk mamagement process
• Approved companies realize significantly lower costs & turnaround times
  

San Franscisco , CA — March 9, 2005 — Distributor review of translated labeling (sometimes termed "Subsidiary Review," "Overseas Review," or "Third Party Review") is a costly, time consuming and problematic step in a company's documentation procedure. Now, thanks to a patent-pending risk management process developed by Crimson Medical Translation and approved by KEMA Notified Body, the typical distributor review step is being safely eliminated.

Companies such as Arrow International, Bio-Rad, Stryker and Cook, are already using Crimson's process to eliminate distributor review, thereby reducing the time and expense of translated labeling.


The Notified Body-approved process is documented in a recently published memorandum from Crimson. A copy of the memo can be downloaded from the Crimson website:

www.medical.crimsonlanguage.com

AT RISK: COMPLIANCE WITH ISO 14971:2000

At the 2004 RAPS annual conference, expert presenters noted that companies may jeopardize their compliance to ISO 14971:2000 if a translated IFU is not an accurate reflection of the English language original. According to this important risk management www.medical.crimsonlanguage.com standard (an FDA consensus standard, referenced by ISO 13485:2003), labeling is the "last line of defense" for managing residual risk.


Therefore, low-quality labeling translation can directly affect conformance to ISO 14971:2000 in overseas markets. Because of their impact on a company's quality system and conformance with the MDD and IVDD, translation providers are considered "critical suppliers" (subject to enhanced risk management scrutiny) under ISO 13485:2003.

In order to satisfy labeling and critical supplier risk management requirements, many companies employ some form of translation review, often termed "distributor review" or "overseas review." However, the review process often gets hung up, bogged down in a time-consuming and costly back-and-forth between translators and reviewers.

ELIMINATE DISTRIBUTOR REVIEW:

One company, Crimson Medical Translation, has recently received Notified Body approval for a strategy that enables companies to safely eliminate traditional distributor review. Explains Crimson's CEO, Marc Miller, "A translation quality system that includes risk management techniques, such as redundancy and diversity, can eliminate the need for further risk management steps, like distributor reviews."

Crimson is the only translation company in the world to be certified to both ISO 9001:2000 and ISO 13485:2003, notes the CEO. The company's patent pending process for translation risk management is based on its certified quality system. This includes both resource and process risk management elements. Aligned with the "process approach" of ISO 13485:2003, these elements work to satisfy the key regulatory requirements of labeling translation, and eliminate the need for distributor review.

Crimson has documented its innovative methodology in a memorandum that was reviewed and approved by KEMA Notified Body. In effect, Notified Body endorsement of Crimson's approach provides companies with the regulatory rationale they need to eliminate this costly, time-consuming and problematic documentation activity.

Adds Miller, "Since our translation risk management approach has received ISO Registrar and Notified Body approval, and regulators are generally obliged to recognize each other's work, our risk management approach can be employed with TÜV, BSI, UL, and other regulatory authorities, to indicate compliance with ISO 13485 and ISO 14971 labeling translation requirements."

The approved memorandum is available for download at Crimson's website:

www.crimsonlanguage.com

VALUABLE MDD, IVDD, ISO & OTHER REGULATORY RESOURCES AT MEDICAL.CRIMSONLANGUAGE.COM:

Also available for download are an IFU Symbols Library (350 electronic labeling symbols), Risk Management Guidelines for Outsourcing, Ed Kimmelman's Quality System Matrix, EU Notified Body Secrets, and Legal Guidance for EU Language Requirements. Some items require a password. Requests for access password can be emailed to: info@crimsonlanguage.com

About Crimson Medical Translation

Crimson Medical Translation, founded in 1992, provides "Expertise in Translation for the Medical Technology Industries." It is the only translation company in the world to be certified to the ISO 13485:2003 and ISO 9001:2000 quality standards. The company's work has been recognized as MDD compliant by an EU Notified Body. Crimson has also received official Notified Body recognition for its innovative application of the SAE J2450 translation quality metric. Extensive use of the metric enabled the company to achieve the first (and only) endorsement to ISO 14971:2000 by a translation company.

The firm's founder, Marc H. Miller, provides management guidance. Mr. Miller holds a degree 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 S.I.A.R., he authored strategic assessments for European and US medical technology firms.

Crimson's specialized approach to medical technology translation has been featured in industry publications such as Medical Device & Diagnostics Industry and Medical Products Outsourcing.

FOR MORE INFORMATION & CLIENT REFERENCES LETTERS, PLEASE VISIT:

www.crimsonlanguage.com