Crimson's provisional patent, "A Method for Analyzing and Managing Risk within the Translation Activity" details innovative methods for controlling risks associated with medical/regulatory translation. It also explains how classic risk management techniques such as Redundancy and Diversity can be used to mitigate translation risk (click here for more on translation risk management). Our process is supported by the use of the SAE J2450 translation quality metric. Combined with our proprietary linguistic QA methodology, BackEditing™, Crimson’s process has received Notified Body approval for translation risk management. According to the endorsement letter from KEMA Notified Body:

Your use of the SAE J2450 metric (in combination with BackEditing™) for in-process QA ensures that persistent serious errors are identified and eliminated.

(Click here to view endorsement letter).

Thanks to our unique process and risk management strategies, Crimson is the only translation company to hold an official registration to ISO 14971:2000. Our registration letter specifically states:

1. Overall process effectively reduces risk by controlling project specifications and handoff risk.
2. 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.
3. Use of the SAE metric to objectify translation vendor evaluation helps to control this acute process risk.
4. Extensive testing procedures for staff and vendors provides critical risk management in the areas of project management, desktop publishing, and formatting QA.

Confidence in our process means that you can have confidence in your translated materials. In fact, with Crimson’s translation risk management processes in place, you can safely eliminate full-document review of your translated labeling (click here for more information)—saving you time, money and frustrating back-and-forth. Call our Boston or San Francisco offices for more information.