Press Release

ISO 13485:2003 REGULATORY QUALITY SYSTEM UPDATE RELEASED BY CRIMSON

• Ed Kimmelman, convenor of ISO/TC 210 Working Group 1 on Quality Systems, unveils proprietary Quality Matrix
• Importance of ISO 9001:2000 vendor certification
• To download pre-release versions of Quality System Matrix & RAPS insert: www.medical.crimsonlanguage.com
  

San Francisco, CA — Jan28, 2003 — Crimson Medical Translation today announced the pre-release of important ISO 13485 regulatory information. Crimson is an ISO 9001:2000 certified translation company whose work has been recognized as MDD compliant by an EU Notified Body.

VALUABLE GUIDANCE FOR COMPLEX REGULATORY QUESTIONS:

Important, pre-released regulatory information is currently available from the Crimson Medical Translation website (www.medical.crimsonlanguage.com). The company's most recent publication, "Regulatory Update: ISO 13485:2003," will be published as a special insert in the Feb. 2003 "Focus" magazine (monthly journal of the Regulatory Affairs Professionals Society).

However, a pre-release version of the insert is now available for download from the Crimson website: www.medical.crimsonlanguage.com

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

The insert contains valuable information from Ed Kimmelman, 35-year industry veteran and former Chairman of the HIMA (now AdvaMed) Standards Section. Based on his insider's perspective, Kimmelman details:

• A proprietary Quality System Matrix for designing a multi-use quality system
• 3 elements necessary to bridge the "Standards Gap" between ISO 13485:1996 and ISO 13485:2003
• 3 important reasons to audit your registrar
• How MDD Harmonization will affect your quality system transition strategy
• How to convert your quality system requirements into opportunities
• Additional opportunities for cost-savings and increased effectiveness

SATISFY IMPORTANT ISO 13485 & MDD REQUIREMENTS THROUGH VENDOR CERTIFICATION:

ISO 13485 requires medical technology companies to maintain strict control over their important outsourced processes. The clearest path for demonstrating the necessary control of outsourced processes is to work with a vendor that has been certified to a recognized quality standard, such as ISO 9001:2000. "Clearly, given the serious regulatory and legal consequences of noncompliance, translation fits into this 'important services' category," Miller points out.

Crimson's "Regulatory Update" provides other important reasons why medical technology companies should insist on certification to ISO 9001:2000 as a means to reduce their vendor audit costs, while ensuring consistent quality. PDF copies of Crimson's ISO 9001:2000 certificate, Quality Manual and Compliance Memo-to-File, are available for download from the company's website: 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."

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