July 21st, 2016
The deadline is coming: On September 24, a UDI compliance deadline will affect Class II devices. If your company is still unsure on how to proceed with UDIs, here are 3 ways you can get yourself ready and avoid non-compliance with the FDA.
July 7th, 2016
UDI compliance has tremendous potential for improving patient safety and helping medical device manufacturers. But like any new piece of regulation, implementation is providing some significant issues.
November 30th, 2015
Regardless of your feelings toward federal mandates, they often provoke changes within an industry. The new FDA mandate regarding UDIs (Unique Device Identifiers) will significantly change how medical device manufacturers approach product development, data integration, and contract manufacture.