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Meeting UDI requirements with GS1 standards


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 our standards, 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?

This course is aimed at any medical device manufacturer trading in the US. Implementation of the regulations will require input from a cross-functional team, so this course is recommended for staff from the following departments:

  • 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
  • The potential of GS1 standards to cut costs and save lives
  • 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
  • Timescales for compliance
  • Identifying different packaging levels
  • Encoding production information
  • Barcode best practice
  • Barcode/label sample review
  • Data requirements
  • Post course implementation support

CPD logoOur training has been CPD certified and certificates are available to all students on completion.

Pricing and how to book this course

Duration: 4 hours (CPD certified)
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 or call us on 0808 178 8799 to discuss your requirements in more detail or to arrange delivery of this course onsite.