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TrueSource for UDI

Your data pool for Global UDI Database (GUDID) compliance

If you supply medical devices to the USA you must comply with the new US FDA 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

1. Load data The medical manufacturer loads the FDA 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.

Our UDI readiness service will help your business to become UDI-ready – whether you supply to the US or the NHS. Find out more