Category: Medical Device Single Audit Program – MDSAP

EU interesting developments – embracing MDSAP and UDI alignment

Medical Devices: The EU will take steps to make use of single audit reports (an initiative of the International Medical Device Regulators Forum – IMDRF) in a manner that is compatible with EU legislative requirements. The EU and US will cooperate to ensure alignment of electronic database specifications for Unique Device Identifiers (UDIs) and will develop a […]