Press Release

CRIMSON MEDICAL TRANSLATION INTRODUCES RISK MANAGEMENT KIT FOR CE LABELING AT 6TH ANNUAL FDA/OCRA CONFERENCE

• CE Labeling Risk Management Kit authored by Critical Path Consultants, sponsored by Crimson Medical Translation
• Kit contains MDD, IVDD, ISO 13485 & ISO 14971 compliant translation SOP,
  Implementation Guidance & all supporting forms
  

San Francisco, CA — July 7, 2003 — First introduced at the recent FDA/OCRA Educational Conference, Crimson Medical Translation today announced the general release of important CE labeling risk management information. Crimson is an ISO 9001:2000 certified translation company whose work has been recognized as MDD compliant by an EU Notified Body.

TRANSLATION SOP COMPLIANT WITH MDD, IVDD, ISO 13485 & ISO 14971 REQUIREMENTS:

Important, CE labeling risk management information is currently available from the Crimson Medical Translation website: www.medical.crimsonlanguage.com.

The company's most recent information, "Risk Management Kit for CE Labeling," first introduced at the 6th Annual OCRA/FDA Educational Conference, is now available at no cost to medical technology companies worldwide.

A PASSWORD IS REQUIRED:

To receive an access password, please email your request to: ksimonsen@crimsonlanguage.com

The Kit, authored by Nicolle Caserma of Critical Path Consultants, is based on translation and risk management requirements outlined in the MDD, IVDD, ISO 13485:2003 and ISO 14971:2000.

The Kit contains:

• A translation SOP designed to identify and manage CE labeling/translation risks
• SOP enables companies to eliminate time-consuming overseas translation reviews
• Guidance document helps to facilitate implementation
• Process Validation Form guards against translation process fraud

TRANSLATION SOP, DESIGNED BY SR. MEDICAL RA/QA CONSULTANT, SATISFIES KEY REGULATORY REQUIREMENTS:

"My background as a quality professional and management representative in the medical device field, combined with my experience in bringing a translation company through a successful ISO 9001:2000 certification audit, make me uniquely qualified to author this SOP," notes Nicolle Caserma of Critical Path Consultants.

Marc Miller, CEO of Crimson Medical Translation and the sponsor of the SOP and Risk Management Kit agrees, "Nicolle has years of experience as a quality professional with medical device companies like Medtronic and Stryker. Based on her work in bringing Crimson to ISO 9001:2000-certifed status, she has a clear understanding of the translation process, inherent risks, and how to effectively manage them through a well-designed process."

The translation SOP is available for download (as part of the CE Labeling Risk Management Kit) from the Crimson website at: www.medical.crimsonlanguage.com

SOP ELIMINATES THE NEED FOR TIME-CONSUMING DISTRIBUTOR REVIEWS:

As part of her work with Crimson, Caserma identified overseas client review (sometimes termed "distributor review") as a source of risk for medical companies developing their CE labeling. Said Caserma, "Most companies want the quality assurance that overseas review provides, but they don't want the endless back-and-forth and delay that these reviews sometimes require."

To address this time-to-market risk, while ensuring translation quality, Caserma's SOP specifies a check for semantic accuracy. "Crimson has a proprietary QA step termed 'Back-editing,' that satisfies the semantic accuracy requirement. However, the simple proofreading step employed by most translation companies does not ensure semantic accuracy. This is an important distinction for companies that are looking to eliminate distributor review."

VALIDATION FORM GUARDS AGAINST PROCESS FRAUD:

A key component of the CE Labeling Risk Management Kit is the Process Validation Form. Designed to supplement the traditional "translation certificate" the form solicits vendor sign-off for each required process step. This helps to avoid "process fraud" - a www.medical.crimsonlanguage.com situation where translation process steps are not completed as specified. "Unfortunately, this situation occurs on a somewhat regular basis,” says Critical Path's Caserma, "I have seen documented instances where translation vendors have not met basic process requirements - even though the requirements were agreed to beforehand."

The surest way to verify that all process steps are faithfully completed is to specify and document them through vendor sign off. "Of course, working with a company that is third party certified to a recognized standard, like ISO 9001:2000, is the best guarantee against this problem," explains Caserma, "That way, the auditor verifies that the translation vendor performs their basic process requirements as specified."

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

Crimson's Risk Management Kit for CE Labeling is only one of many valuable resources available from the company's website: www.medical.crimsonlanguage.com

Also available for download are an IFU Symbols Library (350 electronic labeling symbols), Ed Kimmelman's ISO 13485 Quality Matrix, EU Notified Body Secrets, and Legal Guidance for EU Language Requirements. All items require a password. Requests for access password can be emailed to: ksimonsen@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.

While working as a Senior Research Fellow with the international strategy consulting firm, S.I.A.R., Mr. Miller 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.

FOR MORE INFORMATION & CLIENT REFERENCES LETTERS, PLEASE VISIT:

www.medical.crimsonlanguage.com