Unique Device Identification (UDI) product data submissions require not just that your system for sending data to the...
FDA GUDID UDI compliance: Accuracy required
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Handling UDI Submissions with Software-as-a-Service (SaaS)
Some medical device manufacturers seeking to comply with the FDA’s final rule on Unique Device Identification may want...
GUDID Account Creation: Five Steps to Follow
When medical device manufacturers prepare to submit their device data to the FDA in compliance with Unique Device...
What Your CEO Needs to Know about UDI
Leaders of the regulatory and labeling departments of a medical device manufacturer likely know that complying with...
Step 1 in UDI Compliance: Assembling the Right Team
After working with a number of medical device companies to successfully submit device records to the FDA, one...
4 Questions to Ask Before Choosing a UDI Issuing Agency
As Implantable, Life-Sustaining and Life Supporting (I/LS/LS) and Class II medical device labelers have complied with...
UDI Data Submission: Who is Responsible?
As part of the FDA’s Unique Device Identification (UDI) mandate, medical device labelers are required to submit a data...
One Step in FDA UDI Compliance: The Dun & Bradstreet DUNS Number
In preparing for compliance with the U.S. Food and Drug Administration's final rule requiring Unique Device...