Press Release

RAPS WEST COAST SYMPOSIUM OFFERS EXPERT GUIDANCE FOR ISO 14971 IMPLEMENTATION

• Jeffrey Shaul, ISO 14971 working group member, gives expert guidance for effective implementation
• 8 "Keys for Effective Implementation" & 6 point "Risk Management Plan"
• Guidances are available from Crimson website: www.medical.crimsonlanguage.com
  

Santa Clara, CA — June 15, 2004 — Required as part of the new ISO 13485:2003 standard, ISO 14971 can be difficult to understand and harder to implement. Fortunately, expert guidance for successful ISO 14971 implementation was presented to a recent over-capacity crowd at the RAPS West Coast Symposium in Santa Clara.

Jeffrey Shaul, Risk Assessment Manager at medical device manufacturer Hill-Rom (voting member of the US TAG for the ISO 14971 working group and official observer with the intl ISO committee) unveiled a strategic blueprint for implementation of this complex standard.

Shaul, a graduate of Notre Dame and Indiana University, released highly detailed information in the form of "8 Keys for Effective Implementation" and a 6-point "Risk Management Plan." A guidance document outlining Shaul's presentation is at the Crimson website: www.medical.crimsonlanguage.com.

To receive a required password for access, please email your request to: mmiller@crimsonlanguage.com

DO IT RIGHT THE 1ST TIME:

At the RAPS 2004 West Coast Symposium, experienced industry practitioner, Jeffrey Shaul spoke to an over-capacity crowd and underscored the "strong business reasons for risk management." Shaul pointed out that proper implementation of ISO 14971 can save companies tremendous costs, enable them to foresee problems, and help them "do it right the first time." Shaul's presentation, "A Primer on ISO 14971" provided:

• An informative overview of the ISO 14971 standard
• Understanding of how to apply ISO 14971 to medical device design & monitoring
• Ideas to maximize the effectiveness of risk management activities
• Methods for effectively reviewing risk management results in the design & post-release phases
• A preview of anticipated changes in the next standard release

The complete electronic version of Shaul's presentation, along with other valuable Symposium information will be available from the RAPS bookstore (www.raps.org)

LABELING & IFU REQUIRED TO MITIGATE RESIDUAL RISK:

Point #5 of Shaul's "Risk Management Plan" says that "All residual risk will be mitigated, at a minimum, by labeling and IFUs." This crucial point illustrates the importance of device documentation -- both the English and translated versions -- for risk management.

Says Marc Miller, symposium attendee and CEO of Crimson Medical Translation, "The risk management role of labeling and IFUs in English is easily understood: residual risks are mitigated through documentation (based on Shaul's Risk Management Plan). However, effective risk management is negated if translated labeling is not an accurate rendering of the English original." Due to its importance for risk management, translation has been officially recognized as an "important outsourced service" by Notified Bodies.

SAE METRIC RECEIVES NOTIFIED BODY RECOGNITION FOR RISK MANAGEMENT:

To address this obvious concern, Crimson has adapted a translation quality metric from the Aerospace & Automotive Industry: SAE J2450. Crimson, an ISO 9001:2000 certified translation vendor, has received official Notified Body recognition, endorsement and support for its use of the metric. The well-known Dutch Notified Body, KEMA, offered its support for Crimson's use of the SAE metric for:

• Evaluation of prospective translation resources
• In-process translation QA (in conjunction with Crimson's proprietary BackEditing process)
• Audit of existing translated materials

Based on its innovative and extensive use of the SAE translation quality metric, Crimson is reportedly the only translation company in the world to hold an official endorsement to ISO 14971.

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

Also available for download are an IFU Symbols Library (350 electronic labeling symbols), 196 IVDD Danger-Phrase translations, Ed Kimmelman's Quality System www.medical.crimsonlanguage.com Matrix, EU Notified Body Secrets, and Legal Guidance for EU Language Requirements. To receive a required password for access, please email your request to: mmiller@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.medical.crimsonlanguage.com