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Meeting UDI requirements with GS1 standards

Overview

Being able to identify, track and trace medical devices at a global level enhances quality of care, patient safety and business processes. This is why the US Food and Drug Administration (US FDA) and new EU regulations now require medical devices and in-vitro diagnostics to carry a barcoded Unique Device Identifier (UDI)  a UDI number is needed on the medical device label, its packaging and, in some cases, the device itself.

With the Department of Health, US FDA and EU mandating the use of UDI, it's now critical that these are correctly adopted throughout the healthcare supply chain.

This interactive course will provide the foundations you need for implementation.

Who should attend?
  • Regulatory
  • Pack/label design
  • Sales
  • Marketing
  • Quality assurance
  • Supply chain
What you will learn
  • How the GS1 System is improving healthcare supply chains
  • What manufacturers need to do to meet global regulations for medical devices
  • How GS1 standards are used to automate a variety of use cases, including recalls and inventory management
  • The next steps for GS1 implementation
Course outline
  • GS1 and global healthcare regulations
  • Identifying different packaging levels
  • Encoding production information such as lot and serial numbers
  • Barcode best practice
  • Barcode/label sample review
Pricing and how to book this course

Duration: 4 hours
Member price (up to 8 people): £1,100 plus VAT 
Member price (9+ people): £1,500 plus VAT 
Non-member price: £2,000 plus VAT 

Email training@gs1uk.org or call us on 0808 178 8799 to discuss your requirements in more detail or to arrange delivery of this course onsite.

This course can also be delivered virtually. Contact us to find out more.