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
UK NHS eProcurement: The What, Who, Why and When
If your organization markets medical devices in the United Kingdom, you may have heard about the National Health...
GS1 UDI – How GDSN, GTIN, & GS1 Affect UDI
Simplify global medical device data with UDI, GTIN, GLN, and GDSN standards for regulatory compliance and supply chain efficiency.
UDI Data Security: Why it should be important to you
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.
A Risk-Based Approach to UDI Compliance
As medical device manufacturers scramble to meet Unique Device Identification (UDI) deadlines, a risk-based approach...
UDI: How do I assign Device Identifiers?
As you work on implementing UDI, you may be wondering how to assign the Device Identifier (DI) portion of the UDI to...
FDA GUDID UDI compliance: Accuracy required
Unique Device Identification (UDI) product data submissions require not just that your system for sending data to the...
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...