Empire Blog Meeting FDA UDI Requirements with In-Line Laser Marking of Medical Devices

The serialization or marking of manufactured components has become essential to the highly regulated medical device industry. The FDA, and more recently the European Union, have imposed Unique Device Identification (UDI) requirements in order to improve medical device traceability. Not only does each device require a distinct label, but this UDI information also must be submitted to the appropriate UDI database and stored by the manufacturer. Component manufacturers such as Empire are adapting to meet these needs by investing in the technology necessary for in-line serialization.