Overview
MedStride is a UK-based company building AI-assisted clinical documentation and compliance tools for medical device manufacturers. Their platform helps regulatory affairs teams manage post-market surveillance, clinical evaluation reports, and MDR Article 22 obligations.
As AI capabilities were integrated into the MedStride platform, the team needed a way to ensure that every agent action, from drafting regulatory summaries to accessing patient records, was authorised, traceable, and compliant with EU MDR requirements.
Xybern's authorisation layer was deployed as a mandatory execution pathway inside MedStride's agent infrastructure. Every proposed action passes through five authorisation stages before it can run: Intercept, Identify, Evaluate, Decide, Record. The full decision record is available for regulatory audit at any point.
Key outcomes
Full MDR Article 22 audit trail for all AI-assisted actions.
Real-time authorisation of regulatory rules in clinical documentation workflows.
Zero unauditied agent executions across the MedStride platform.
Compliance evidence ready for notified body review without manual reconstruction.
