Medical device labelers, including manufacturers, repackagers, and reprocessors, as well as those involved in implementing or managing UDI, such as master data managers, package design and management teams, and operations and IT personnel.
Looking for Expert Guidance on Your Medical Device Labeling to Meet UDI Requirements?
The GS1 Standards for U.S. FDA UDI Online Certificate Course is designed specifically for medical device labelers—including manufacturers, repackagers, and reprocessors—or anyone involved in implementing Unique Device Identification (UDI). It offers the opportunity to learn key concepts related to product identification, medical device barcoding and labeling, and data submissions to the Global Unique Device Identification Database (GUDID) of the U.S. Food and Drug Administration (U.S. FDA).
You will also gain a deep understanding of GS1® identification keys, barcode types, and data standards that can be used to implement U.S. FDA UDI Rule* requirements while also enhancing operational efficiency for your supply chain.
Equipped with the knowledge from the GS1 Standards for U.S. FDA UDI Online Certificate Course, you can:
Adopt a unified and standardized approach to medical device identification and labeling to boost patient safety
Help ensure data integrity and accuracy for seamless tracking and tracing of products throughout your supply chain
Properly format Global Trade Item Numbers (GTINs) to facilitate efficient and accurate data capture
Earn a Professional Credential
Add Credibility to Your Resume With GS1 US Badges
You can earn an important credential in the use of GS1 Standards by successfully completing a GS1 US® certificate course. This badge is a testament to your commitment to professional development, making you a distinguished member of a global supply chain community. Display your badge on your online resume or social media profiles to showcase your expertise and stand out with your credential.
What to Expect
Access On-Demand Modules With Step-By-Step Guidance
GS1 Overview
How GS1 Standards make it possible to identify, capture, and share information automatically and accurately about products, business locations, and more
GS1 Company Prefix
Basis for creating all GS1 identification keys, highlighting the difference between GS1 Company Prefix and UPC Company Prefix
GTINs
Overview of different types of GTINs, how they are used, and how to construct GTIN-12, GTIN-13, and GTIN-14
GTIN Management Standard
The guiding principles of the 10 GTIN Management rules that can be used to make consistent decisions on when a new GTIN may be needed
GS1 Barcodes
Overview and uses of different barcode types, including 1D barcodes such as EAN®/UPC, GS1-128, and ITF-14 and 2D barcodes such as GS1 DataMatrix and QR Codes
Overview of the U.S. FDA UDI Rule, Definitions, and Exceptions
Overview of key definitions, exceptions, and valuable implementation resources, including frequently asked implementation questions
Enhance Your Team’s Skills and Save With Volume Discounts
Set your company up for success by expanding your team’s knowledge in the adoption and use of the GS1 System of Standards. The more seats you buy, the more you can save while also increasing your bench strength to provide accurate product data to your customers and trading partners. All attendees receive a full year’s access to course materials.
GS1 Foundations for Healthcare Online Certificate Course
Are you a healthcare professional who manages the product life cycle from creation, item setup, and packaging through distribution, marketing, product management, supply chain operations, and logistics? If you answered yes, you may want to consider the GS1 Foundations for Healthcare Online Certificate Course. This course covers the foundational aspects of globally unique healthcare product and location identification and barcoding with GS1 Standards.
Need More Help?
Please fill out this form to speak to a training specialist today! Or contact us at training@gs1us.org.
*For information about the rule, see the U.S. FDA Unique Device Identification System
GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved, or authorized by the U.S. FDA. GS1® is a U.S. FDA-accredited issuing agency for UDI, and GS1 Standards are authorized for use in implementing the requirements of the U.S. FDA UDI Rule.
Please be advised that this content was created generally for GS1 Company Prefix holders. If you licensed a single GS1 identifier (i.e., GS1 US GTIN), we recommend evaluating this offering carefully to ensure its applicability to your business needs. The information provided is for educational purposes only and does not constitute legal or business advice.
