Linked reference records
Aletia links devices relevant to your market to available FDA, MHRA and EU EUDAMED records under a persistent device identity.
Aletia Pathways
For Regulators
Reliance needs a post-market layer.
Designed for national regulators, ministries of health and harmonising systems that rely on foreign regulatory evidence while retaining responsibility for local oversight.
When you rely on a foreign approval, you inherit its decision — not its surveillance.
Reliance pathways allow your authority to draw on decisions and evidence from trusted reference jurisdictions when assessing a device for your market. But regulatory evidence is not static. A recall may be issued, a certificate may lapse, a safety signal may emerge, or the product itself may change.
That signal does not always propagate automatically into the local oversight workflow. The local decision may remain standing after the evidence beneath it has changed.
What Aletia provides
Post-market visibility
Monitor recalls, certificate changes, stale information and other lifecycle events that may require local review.
Supplier-side attestations
Where appropriate, suppliers can confirm local listings, accountable contacts, product versions and material changes on a defined cadence.
Traceable alerts
Each alert is source-linked and time-stamped, creating an auditable trail for human review rather than an unverified signal.
What your authority can monitor
- Recalls, corrective actions and safety signals raised in a reference jurisdiction.
- Registrations and certificates that have lapsed, been suspended or are approaching expiry.
- Differences between devices visible in foreign registries and devices listed locally.
- Supplier records that have not been confirmed within the required period.
- Lifecycle changes affecting AI/ML-enabled devices, where software updates, model changes and post-deployment performance require particular attention.
Working with a regulator, ministry of health or health-system programme?
Tell us about your jurisdiction and the oversight problem you are trying to solve.