1. A system for preparing a translation of a labeling document from a source to at least one target language, the system comprising: a medical device having a quantifiable risk classification; a medical device labeling document in the source language, the labeling document having an intended use in connection with the medical device and being translated from the source language to the at least one target language; and a risk calculator for assessing the translated labeling document for potential risk to a human from use of the medical device as a function of: the medical device risk classification, the intended use of the labeling document in the at least one target language, the source language, and the at least one target language, wherein the risk calculator requires additional translation efforts when the assessed potential risk exceeds a risk threshold.
7. The system of claim 1 further including means for back-editing the translation document to review the translation using a translator whose native language is the source language.