Press Release
NOTIFIED BODY DECLARES TRANSLATION AN "IMPORTANT OUTSOURCED SERVICE," SUBJECT TO ISO 14971 RISK MANAGEMENT CONSIDERATIONS
- Notified Body issues opinion letter on translation service classification
- Translation providers subject to ISO 13485:2003 & ISO 14971 risk management requirements
- Crimson Medical Translation receives Notified Body endorsement for risk management process
- Crimson earns 1st-ever endorsement to ISO 14971 risk management standard
San Franscisco , CA — September 16, 2004 —
A Notified Body opinion letter was recently issued that clarifies the regulatory status of language translation services. According to the KEMA Notified Body, "Due to compliance implications for the essential requirements of the MDD and IVDD, 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."
The full text version of the KEMA opinion letter is available from Crimson’s website:
www.crimsonlanguage.com
A password is required for access. To receive a password, please email your request to: mmiller@crimsonlanguage.com
NOTIFIED BODY ISSUES OPINION LETTER:
The Dutch Notified Body, KEMA, recently issued an opinion letter regarding vendor classification. According to this highly respected CE auditor, translation services fall under the heading of "important outsourced service," due to the MDD/IVDD compliance implications of their work. In issuing this guidance, KEMA also indicated that translation providers are subject to the stringent outsourced vendor risk management considerations of ISO 13485:2003 and ISO 14971.
POOR TRANSLATION JEOPARDIZES ISO 14971 RISK MANAGEMENT ACTIVITIES:
In addition to implications for MDD and IVDD compliance, translation also has critical implications under the new ISO 14971 risk management standard. Under ISO 14971, all residual risk must be mitigated (at minimum) through labeling and IFUs. Satisfying this requirement through the use of English documentation is straightforward. However, companies may jeopardize their ISO 14971 compliance in international markets if their translated labeling and IFUs are inaccurate.
TRANSLATION QA METHODOLOGY ENDORSED BY NOTIFIED BODY:
In order to meet the stringent requirements of ISO 13485:2003 and ISO 14971, one company has developed a unique translation QA methodology. Crimson Medical Translation (ISO 9001:2000 certified) has received official Notified Body endorsement for a process that is designed to identify and eliminate serious translation errors. Crimson employs a proprietary review process [BackEditingTM], in combination with a recognized translation quality metric (SAE J2450) adapted from the automotive and aerospace industries. Crimson's QA methodology has received Notified Body support for:
- Evaluation of translation resources
- In-process translation QA
- Audit of existing translated material
According to the company's endorsement letter, "Identifying and preventing serious errors is the key translation risk management consideration (a serious error is one that may result in patient harm). In this regard, your adaptation and use of the SAE translation quality metric (SAE J2450) is supported by KEMA..." The full text endorsement letter is available online: www.medical.crimsonlanguage.com
EFFECTIVE RISK MANAGEMENT WINS NOTIFIED BODY ENDORSEMENT:
Based on its innovative QA methodology, Crimson is the only translation company to hold an official endorsement to the ISO 14971 risk management standard. According to Crimson's endorsement letter, "Crimson's BackEdit process provides critical risk management through a linguistic QA check. Your use of the SAE translation quality metric to produce a measurable, statistically based scoring system is particularly insightful," and "Your use of the SAE metric to objectify translation vendor evaluation helps to control this acute process risk." A full text version of the ISO 14971 endorsement letter is also available online: www.crimsonlanguage.com.
Crimson's CEO, Marc Miller, underscores the importance of risk management in the translation process, "Increased EU surveillance of product labeling was announced at this year's RAPS Symposium. Not only are Competent Authorities focused on labeling, but they have also formed a new committee (NSOG) to coordinate and share the results of
their findings." Adds Miller, "The labeling requirements of the new ISO 14971 standard make translation risk management more important than ever before."
VALUABLE MDD, IVDD, ISO & OTHER REGULATORY RESOURCES ARE ONLINE:
In addition to electronic versions of the Crimson endorsement letters, there are a large number of other valuable resources available at Crimson’s website: www.medical.crimsonlanguage.com.
Also available for download are an IFU Symbols Library (350 electronic labeling symbols), an update on the status of Electronic Labeling for the EU, Jeffrey Shaul's ISO 14971:2000 Implementation Guidance, ISO 13485:2003 Outsourcing Guidance, IVDD Danger-Phrase translations, Ed Kimmelman's Quality System 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: 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.crimsonlanguage.com
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