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TrueSource for UDI

Your data pool for Global UDI Database (GUDID) compliance

TrueSource UDI

If you supply medical devices to the USA you must comply with their UDI regulations. Part of the regulations states that your production data must be stored within the Global UDI Database (GUDID) specified by the US FDA.

Our TrueSource data pool meets all requirements for interoperability with the GUDID. This means it provides a single point of entry for publishing a medical device’s product master data to the GUDID.

Using TrueSource helps compliance with a direct interface – removing any technical complexity and reducing costs for your organisation.

TrueSource UDI solution - product data flow

UDI TrueSource Data Flow

1. Load data The medical manufacturer loads the required product data
2. Publish data The medical manufacturer publishes the required product data via TrueSource, to the FDA GUDID
3. Confirm & inform FDA sends a confirmation to TrueSource. The confirmation is then passed, by TrueSource, to the manufacturer, with notification regarding successful transmission or potential errors. A detailed report will be made available to the medical device manufacturer.

TrueSource provides a secure environment to enter and maintain medical device product information, and secure communication of this information to the FDA GUDID.

TrueSource provides a secure environment to enter and maintain medical device product information, and secure communication of this information to the FDA GUDID.

UDI readiness service

This service will help your business to become UDI-ready – whether you supply to the EU, US or the NHS. We will work with your business to help you understand what is required, to collate the data needed and to have it entered into TrueSource ready to publish.

It’s an online service that includes:

  • Creating bespoke XLS upload templates to meet the NHS requirements
  • How to code data in the User Interface (UI) and use the XLS upload templates
  • Releasing and publishing your data
  • Creating UI templates
  • Upload and download of an item
  • Ability to check for exemptions and errors using TrueSource in-built validations

To find out more, just get in touch with our healthcare team.


TrueSource UDI -
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