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Pop quiz: For the purposes of FDA Unique Device Identification (UDI), is an anterior cruciate ligament (ACL) procedure kit considered one medical device, i.e., a “convenience kit?” That question is one of many addressed by the FDA’s final guidance on Unique Device...
Is your team evaluating UDI regulatory submissions for EU and other regions? All the complexity around UDI regulatory (and commercial) requirements across the globe create serious challenges for product data management. When considering what’s at stake, a...
The FDA Unique Device Identification (UDI) regulation requires manufacturers to identify their medical devices with a UDI placed on their product and package labels. Of equal importance, the FDA UDI regulation also requires manufactures to report medical device...
In December 2018, the National Health Service (NHS) England announced an extension to its eProcurement deadline for in-vitro diagnostic devices. Instead of being required to comply by September 2019, manufacturers now have until September 2021. I caught up with Gary...
HORSHAM, Pa., March 25, 2019 /PRNewswire/ -- Reed Technology and Information Services Inc. (Reed Tech), a leader in data management and analytic services and solutions for the Life Sciences industry, announces the launch of Reed Tech SingleSource™ for Medical Devices....
What are the required actions when a product includes both a medical device constituent and a drug constituent? Learn more from Reed Tech
Global Location Number (GLN) A Global Location Number (GLN) is a 13 digit number that acts as a key for identifying the location, whether physical or digital, and the function or entity of a company across the supply chain. A GLN gives companies complete flexibility...
What is the Global Data Synchronization Network? The GDSN is the largest online product data network. It’s a secure network that allows any agents, such as manufacturers, retailers, distributors, and wholesalers to share validated product information. Because of its...
Simplify global medical device data with UDI, GTIN, GLN, and GDSN standards for regulatory compliance and supply chain efficiency.
Data security has three facets—confidentiality, integrity and availability. Device labelers need to keep each of these areas in mind when it comes to managing the UDI data for their device portfolio.