Global Medical Device Podcast Powered By Greenlight.guru

Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner

Informações:

Synopsis

If you are part of an organization developing or producing Class II medical devices, you should know that on September 24, 2016, your UDI submissions are due to the FDA. “I don’t mean to scare anyone, but we only have 78 working days left.” - Gary Saner UDI stands for “unique device identification,” and the new labeling regulations have been put into place to increase patient safety, reduce medical errors, and provide a foundation for secure global distribution of devices. Today’s guest, Gary Saner, is an expert on UDI submissions and other regulatory topics. As the Senior Manager of Information Solution at Reed Tech, Gary is speaking to us today about the UDI submission procedures and other relevant topics. “The UDI submission is not a one-time effort.” - Gary Saner With over 30 years’ experience in software management and data conversion, Gary is the go-to person if you have questions about UDI, and his company can help medical device companies of any size be sure that their submissions are in order.