UDI and Product Data
This page provides blogs, short videos and recordings focused on industry insights for regulatory requirements and best practices to manage medical device product data for established and newly formed Health Authority UDI mandates around the world.
Recent Blogs
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...
Webinar Recording: Challenges and Considerations for Building Your Own UDI Solution
Is your team evaluating UDI regulatory submissions for EU and other regions? All the complexity around...
Reference Checklist: FDA Medical Device UDI Regulation Records, Reports, SOPs
The FDA Unique Device Identification (UDI) regulation requires manufacturers to identify their medical devices with a...
Reed Tech® Introduces Reed Tech SingleSource™ for Medical Devices Supporting UDI Requirements around the Globe
HORSHAM, Pa., March 25, 2019 /PRNewswire/ -- Reed Technology and Information Services Inc. (Reed Tech), a leader in...
Combination Product: What to Consider for both Medical Device and Drug Constituents
What are the required actions when a product includes both a medical device constituent and a drug constituent? Learn more from Reed Tech
What is a GLN (Global Location Number)?
Global Location Number (GLN) A Global Location Number (GLN) is a 13 digit number that acts as a key for identifying...