Services
AU Tier 0โ1 focus: monitoring, recall readiness, and closure proof
Recall Watch
Monitor AU-linked signals and convert them into watch records, pre-cases, and hospital review queues.
Recall Ready
Match signals to local inventory, support route decisions, track actions, and generate evidence-backed audit packs.
Audit-Ready Closure
Prove which local assets were affected, what was done, what exceptions remain, and whether verified closure can honestly be claimed.
How it works
The hospital-facing workflow
Receive and classify the signal
Separate authoritative AU action from sponsor notices, FDA/global watch signals, and internal incidents.
Confirm the device and local exposure
Link the device to the Australian supply context, then match the local hospital inventory by model, lot, serial, or configuration.
Run the workflow and gather proof
Track actions, support the reporting route, store proof, manage exceptions, and export the closure pack.
Evidence-led value
The platform boundary is practical and auditable
In-platform
Notice records, inventory reconciliation, local actions, submission proof, exception handling, and closure sign-off.
Hospital-local
Clinical files remain inside hospital systems. ROQAIAH stores references and attestations, not patient content.
Trust & Hosting
What the current draft is designed to say clearly
Offer boundary
Workflow support, evidence management, and auditability. Not a claim of direct regulator API automation.
Deployment posture
Hosting, access, breach-response, and cross-border support model are implementation decisions that require final legal and technical sign-off.
Why the platform exists
The underlying operational gap