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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...
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.
As medical device manufacturers scramble to meet Unique Device Identification (UDI) deadlines, a risk-based approach to UDI compliance will help ensure continuity within the quality system, consistency in UDI practice and application, accuracy of the associated data...
As you work on implementing UDI, you may be wondering how to assign the Device Identifier (DI) portion of the UDI to your products and how to make sense of the different levels of DIs in a single GUDID record. These are questions we receive from industry members all...
Unique Device Identification (UDI) product data submissions require not just that your system for sending data to the FDA’s Global Unique Device Identification Database (GUDID) be in place and functioning smoothly. It requires that the data you send through that...
Some medical device manufacturers seeking to comply with the FDA’s final rule on Unique Device Identification may want to turn to outside firms for help throughout the process. Others may already have the expertise in-house to handle their UDI compliance and FDA GUDID...
When medical device manufacturers prepare to submit their device data to the FDA in compliance with Unique Device Identification requirements, one of the prerequisite steps for all manufacturers is to establish a Global Unique Device Identification Database account....