When it comes to medical devices, patient safety is always a major concern and, as a result, so is the liability of medical device manufacturers. The safe use of medical devices is regulated by governmental agencies in many countries and incidents associated with the incorrect use of devices are tracked and reported periodically.
Medical device manufacturers are very sensitive to risk assessment and mitigation. Yet, when it comes to minimizing risk, not all medical device manufacturers consider medical translation to be an important outsourced activity, despite the fact that Notified Bodies consider it to be critical. The following report explains why.