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
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...