Medical Devices: Mandate for Safety in Any Language


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Medical Devices: Mandate for Safety in Any Language

The Gilbane Group - August 30, 2007

Crimson Life Sciences, a division of TransPerfect, Inc., recently announced that it has been certified by Underwriters Laboratories as compliant with ISO 14971, the "only international standard for risk management for medical devices." According to UL, "ISO 14971 has become an integral element for satisfying regulatory requirements in most major markets." Crimson's certification relates to risk management processes for translating medical device labeling and documentation.

The announcement caught our attention because medical device manufacturing is one of the verticals on the Gilbane globalization practice radar. It's a huge market in which significant opportunity is spread across the globe. Just one proof point: according to RIC International, "25% of medical devices produced in the US are exported, with diagnostics comprising the largest export sector." As such, this vertical is generating a significant amount of the demand for solutions that integrate content management and translation process management in a global content life cycle. Which is why it's of particular interest to us in Gilbane's globalization practice.

Medical device manufacturers face some of the most rigorous challenges associated with content translation. They must create, translate and publish product support content that describes medical devices, documents proper procedures, complies with global regulations, and enables best practices. The risks associated with poorly translated content are particularly onerous for these companies. Crimson Life Sciences recognized this and went the extra mile have its risk management methodologies for translation validated by an international certification authority.

An important sub-theme here is quality of translated content and translation processes. Today, quality measurement is a mix of science and art (science in the case of industries with established standards such as SAE J2450 in automotive). Crimson's UL certification is another step towards taking some the mystery out of quality verification.

The issues of multi-lingual content, translation processes, quality, and brand management come together in a case study on GE Healthcare that Gilbane will publish this fall. We're also working on a white paper that identifies opportunities to insert quality improvements into the global content life cycle. For insight into content-related business issues in medical device manufacturing in the meantime, see our case study on Siemens Medical, and check out the archived webinar we did earlier this summer with Medtronic. We'll also be covering quality and the global customer experience as the theme of the globalization sessions and keynote at Gilbane Boston 2007.

 
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