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Recent Blogs
Fact vs Fiction: UDI in China and Global Data Pools
LexisNexis Reed Tech has been planning and developing connectivity for NMPA for some time. China UDI requires about fifty data attributes. About half of these attributes are already supported by Reed Tech SingleSource™ for Medical Devices. To date, preliminary case scenarios are already in the test development phase. It is anticipated that some business rules will materialize and change between now and the 2020 October UDI submission date.
Global Data Synchronization Network
Why your product data needs to be in GDSN…NOW! If you manufacture medical devices, you know the challenges in managing...
Fact vs Fiction: GDSN Connection
Author: John Lorenc, Sr. Manager Regulatory Solutions, Reed Tech Fiction: Most global health authorities subscribe to...
Reed Tech Selected by The Vision Council as the full-service solution for UDI
Reed Tech is proud to be recognized as the full-service solution for Unique Device Identification (UDI) to US FDA and...
Reed Tech Insights: US FDA and EU EUDAMED Comparisons
Take a ‘deep-dive’ into understanding and preparing medical device product data for EU EUDAMED UDI submissions. Learn more about the data attributes, regulatory, legislation and distinct differences between US FDA GUDID and EU EUDAMED.
A Closer Look at the FDA’s UDI Guidance: Which Convenience Kits Need UDI? Which Don’t?
Pop quiz: For the purposes of FDA Unique Device Identification (UDI), is an anterior cruciate ligament (ACL) procedure...