White paper
How Xybern meets MDR Article 22 requirements for AI-assisted medical devices.
This white paper examines the regulatory landscape for AI-enabled medical devices under EU MDR, and demonstrates how Xybern's authorisation layer provides a technically and legally defensible authorisation mechanism for Article 22 compliance, with a case study on the MedStride deployment.
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Run a pilot of the Xybern Authorisation Layer in your organisation and watch every agent action authorised, and sealed to the vault.
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