Coridian UDI Solutions

UDI

Coridian offers a full global UDI compliance solution that guides our clients through both understanding the UDI rules and also provides the services to help them achieve successful implementation of their UDI compliance project from labeling and verification to GUDID data submission. Let Coridian help you comply. Call 952-227-9129 or email us at udi@coridian.com.

The Compliance Requirements

US - Class I, II and III devices distributed in the United States must carry a Unique Device Identifier or UDI and all manufacturers are responsible to upload accurate device data to GUDID and put in controls to maintain data and record all changes.
EU MDR - Class I, IIa, IIb, and III devices distributed in the EU must carry a UDI and all manufacturers are responsible to publish accurate data to EUDAMED and put in controls to maintain data and record all changes.
Learn more by viewing our Spring 2019 webinar EUDAMED and Labeling Challenges of the EU MDR
NHS eProcurement - Class I, IIa, IIb, and III devices distributed in the UK must carry a GS1 only UDI and all manufacturers are responsible to publish accurate data to the GDSN and put in controls to maintain data and record all changes.
PEPPOL - All companies that trade with EU and UK government entities will be required to use PEPPOL to receive purchase orders and send invoices.

The Business Challenge

Average implementation time is 6 – 12 months
The FDA estimates initial cost of compliance 1 – 5% of company revenue. That cost triples if first attempt done incorrectly and corrections need to be made.
Both a project that needs to get done and a process that needs be implemented for long term compliance.

Enterprise UDI Software Solution Case Study (PDF)

UDI Labeling Solutions

Verification Solutions

Coridian UDI Solutions (PDF)

Guide To FDA UDI Compliance (PDF)

Get in Touch
1725 Lake Drive West
Chanhassen, MN 55317
Phone: (952) 361-9980
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