In SoftwareCPR’s experience, translations and localization of user interfaces and labeling of medical devices for distribution in a variety of geographic regions can be challenging and can present safety issues if not properly handled.  Alan Kusinitz of SoftwareCPR® co-authored an article on localization risk management with one of the large companies that provides such services...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. 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...Read More