Obligations calendar
Use this as the default first screen for Australia. It anchors the platform to the dates that matter operationally and helps frame urgency without overclaiming automation.
Healthcare-facility Stage 1 mandatory reporting starts
Australian hospitals must report death, serious injury, or serious deterioration events involving high-risk devices in the first stage. The testing platform treats this as the main reporting clock for ASDER/IRIS route logic.
UDI starts for Class III and Class IIb devices
This is the first major AU device-identity milestone relevant to high-risk and implantable medical devices. It supports device master enrichment and later serial-level workflows.
Healthcare-facility Stage 2 starts
Medium-risk device events and near misses expand the mandatory reporting scope. This is where the production platform needs mature routing, proof, and inventory readiness.
UDI starts for Class 4 and Class 3 IVDs
Keep this visible in the obligations view because the timing matters for AU roadmap conversations and data-model readiness.
Platform interpretation
Fast-refresh recall and reporting logic first. Scheduled master-data refresh second. Local inventory and proof remain the decisive closure layer.
Commercial interpretation
Hospitals need workflow, proof, and closure confidence before they need architecture depth. That is why the testing platform comes first and the demo layer stays separate.
Proof of need
Use this editable model during testing and outreach. Figures are scenario inputs, not legal or financial advice.
Proof-of-need blocks for the main page
These blocks can be shown before launch into either the testing platform or the demo. They keep the first page operationally persuasive without pretending to offer legal cost guarantees.
Serial-scoped recalls still leave hospitals blind
Global recalls may publish serials without country allocation or hospital mapping. The local inventory bridge is what turns signal into exposure truth.
Reporting and proof failures are workflow failures
Operational risk comes from missed route decisions, missing submission proof, incomplete exception handling, and weak closure evidence, not only from device defects themselves.
Reduce dependency on scattered specialist work
Structure the case once so biomedical, quality, governance, IT, and external advisors work from one evidence chain instead of recreating the case repeatedly.