Abstract: Methods for analyzing, evaluating, and controlling risk of errors in language translation of medical device labeling are disclosed. The disclosed methods include identifying the risk level of the device; identifying the safety function(s) of the content that is translated; evaluating risks associated with the translation process; and analyzing this risk information and applying it in the selection of resources and in the design and execution of processes, to effectively mitigate the risk of safety related translation errors in labeling for medical devices.