We formed UDI Compliance Solutions, LLC to help make the path to compliance easier and faster!
The FDA UDI mandate calls for the placement of Device Identifiers (DI) and Production Identifiers (PI) on a UDI label.
The FDA deadlines serve to give medical device companies a target date to shoot for, however
The premise on which the concept of a unique identifier is founded is far too important and far more complex than just having to label a medical device a certain way.
The Unique Device Identification (UDI) system mandated by the FDA is designed to protect patient safety and require the proper identification of medical devices.
As the effective dates for UDI Compliance and enforcement edge closer there is suddenly a huge waive of information that is becoming available on a daily basis with regard to the suggested best practices and necessary filing requirements of the new FDA regulations and GUDID filing system. Unfortunately, as is often the case with documentation […]