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Crimson Life Sciences which performs language translations for labeling and user interfaces was assessed by Underwriters Laboratory for conformance with the ISO 14971 Medical Device Risk Management standard.
The summary of the audit results is available at this link (Crimsonriskmanagementguidanceformultilingual labeling-memo) and is provided with the permission of Crimson. This report contains some important insights by UL (including by Harvey Rudolph formerly of FDA) regarding the importance of risk management for translations and states that Notified Bodies consider translation to be an “important outsourced service” which makes translation providers subject to ISO 13485 and 14971.
A reprint of an article regarding Translation/Localization risk management published in the AAMI BIT journal and co-authored by Kai Simonsen of Crimson and Alan Kusinitz of SoftwareCPR is provided elsewhere on this site.
Crimson Language appears to be the first such company to obtain certification to ISO 14971:2000. Their website is http://www.crimsonlanguage.com/. SoftwareCPR has no financial connection to Crimson Language but does occasional consulting for them.