Medical device labeling: The unsung pillar of patient safety and compliance

Having the correct documentation is a key bottleneck in achieving outcomes for medical device manufacturers. Before a device can be shipped or delivered, it must have valid Labeling and Instructions For Use (IFUs). The relevant documentation must be available in the correct language and localized to meet jurisdictional requirements such as the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).. .