Management Information Systems > UDI Compliant Systems

UDI Compliant Systems

To meet the legislation requirements of the Food and Drug Administration, medical devices distributed in the United States must carry a unique device identifier (UDI). The UDI initiative has been introduced to improve patient safety, product quality and traceability accuracy. With a UDI compliant solution in place, medical devices can be tracked throughout the supply chain.

Devices have been divided into three categories (Class I, II and III) and the introduction of UDIs for these different classes is taking place in different phases. The UDI regulatory requirements are in place for most Class III and Class II devices distributed in the US and will be applied to medical device products distributed in the US, Europe, The Middle East and Africa (EMEA) and the rest of the world between now and 2020.

ITS offers a range of 21 CFR Part 11 and CFR Part 820 compliant UDI automation solutions to assist medical device manufacturers in meeting the regulatory requirements. The solutions can include any of the following services and solutions:

  • Production of UDI User Requirement Specifications
  • Automation solutions integrated with ERP or database(s) to receive work flows and associated UDI data
  • Integration of label management solutions offering a full audit trail, approval process and archiving
  • Installation of print management solutions
  • Design and implementation of vision systems and code readers to verify that any data printed on each device or label is eligible and correct
  • 21 CFR Part 11 and CFR Part 820 compliant database solutions to record the UDI traceability data applied to each product for each batch for reporting purposes with audit trail
  • Validation services for UDI automation solutions
  • Provision of UDI consultancy
  • Integration of UDI compliant solutions with production systems e.g. OEE, situational awareness to improve operational performance

ITS’ team has been working in the medical device industry since the company started in 1991. Since then we have gained extensive experience in offering fully validated automated solutions to improve product quality, patient safety, traceability and UDI compliance. The solutions that ITS offers are flexible and can be integrated with different ERP systems to automatically receive work-flows and UDI data. The solutions are designed to improve product quality by automatically inspecting products and labels and accurately tracking medical devices throughout the entire production process. The UDI compliant systems integrate with label and print management solutions, to ensure that the right label and data is applied to each device. As an independent company, ITS works closely with its medical device clients to understand their requirements and recommend the best solutions to help them achieve regulatory compliance.



Contact our team today

For further information, please contact
our team on +44 (0)1642 222232 or
email enquiries@its-ltd.co.uk