✚
Healthcare-first positioning
Structured for hospital quality governance, recall operations, and auditable closure workflows — not generic software.
⚠ TGA Stage 1 — effective 21 March 2026
AU-hosted
Evidence-backed closure
Medical device recall governance — verified,
audit-ready.
ROQAIAH helps Australian hospitals receive, action, and close medical device recall notices — with the structured evidence trail your quality team needs for TGA mandatory reporting.
10Calendar days — TGA Stage 1 mandatory reporting window
1 JulTGA UDI phase-in — Class III devices & Class 4 IVDs
ROQ 1–5Maturity levels — from notice-driven to verified closure
Synthetic demo preview
Notice-to-closure workflow
Step 1Notice intake & TGA reference
Step 2Device triage & inventory match
Step 3Owner assignment & 10-day clock
Step 4Evidence pack — RCES aligned
Step 5Exception log & risk decisions
Step 6Verified closure & audit export
Open notices2Illustrative intake queue
Exceptions3Pending risk decisions
Closure rate86%Sample KPI — demo only
Regulatory basis
Therapeutic Goods Act 1989 — mandatory facility reporting
Privacy Act 1988 — APPs 1–13
ASD Essential Eight ML1 — baseline from launch
Azure Australia East — data sovereignty
ISO 13485 — QMS alignment
TGA Stage 2 — from 2027
Why hospital buyers trust the model
A service design shaped for credibility, not hype.
The platform is written to signal discipline: clear boundaries, measured claims, controlled support, and a governance-first product story appropriate for healthcare procurement environments.
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Operational, not clinical
Designed around workflow, evidence, and oversight rather than diagnosis or treatment decisions. TGA exclusion lane maintained.
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Controlled hosted service
Single-tenant AU-hosted model with isolated tenancy, zero standing vendor access, and JIT support only.
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Executive-grade visibility
Built for quality leads, biomedical engineering, risk, procurement, and executive oversight — all in one platform.
The recall execution gap
Hospitals receive recall notices. Proving they acted on them is the hard part.
When a notice arrives, the work begins: tracking devices across wards and sites, coordinating teams, collecting evidence, managing exceptions, and producing a defensible closure record.
Problem 01
Action tracking is fragmented
Recall notices arrive from TGA, manufacturers, and distributors — managed in spreadsheets and email threads. No single record of what was done, by whom, and when.
Problem 02
Closure cannot be proven without structured evidence
TGA mandatory reporting requires demonstrated recall completion. An email chain is not a verified closure record. Exceptions need documented risk decisions that hold up to audit.
Problem 03
The 10-day mandatory reporting clock starts immediately
For death or serious deterioration events involving high-risk devices, TGA Stage 1 requires a report within 10 calendar days of becoming aware. The clock does not wait for internal processes.
Problem 04
Inventory matching is manual and error-prone
Matching a recall notice to affected stock across wards, theatres, and stores is time-consuming without a structured system. Devices can be missed — with no audit trail to prove otherwise.
This is a CEO-level obligation
TGA Stage 1 places formal mandatory reporting obligations on healthcare facilities. Quality leads, biomedical engineering teams, and hospital executives need a consistent, repeatable process — not a one-off response each time a notice arrives. ROQAIAH is that process.
How it works
From TGA notice to verified closure — one platform.
Five steps. One repeatable process. An evidence trail at every stage.
1
Notice received
TGA alert, manufacturer or distributor notice captured as a structured case
2
Device triage
Affected devices matched to inventory by ward and site. 10-day clock starts
3
Action & evidence
Actions assigned. Evidence uploaded against RCES artefact classes
4
Exceptions logged
Devices not recovered documented with reason code and risk decision
5
Verified closure
Named authorised sign-off, timestamp, audit-pack exported and retained
Service tiers
Start free. Scale when you are ready.
Three tiers designed to meet hospitals where they are — from a weekly intelligence digest to a full hosted recall operations platform.
Tier 0
Recall Watch
Free — no commitment
Weekly TGA recall intelligence to your quality inbox. No software, no data required.
- ✓Weekly TGA device recall digest
- ✓Class I recall alerts — death / serious injury scope
- ✓Stage 1 mandatory reporting updates
- ✓ROQ maturity self-assessment guide
- ✓RCES evidence checklist (PDF)
- ✓Monthly 20-minute advisory call
Tier 1 — Recommended
Recall Ready
AUD 30–50K + AUD 12–18K / yr
AU-hosted recall operations platform. Structured, evidence-based, audit-ready.
- ✓Everything in Recall Watch
- ✓Hosted recall case management platform
- ✓10-day TGA reporting countdown & alerts
- ✓Device triage & inventory matching
- ✓Evidence pack — RCES artefact aligned
- ✓KPI dashboard & audit-export PDF
- ✓UDI capture — 1 July 2026 ready
- ✓Azure Australia East — data sovereignty
Tier 1.5 — Network
Recall Ready Network
Negotiated — multi-site groups
For hospital groups managing recall governance across multiple sites.
- ✓Everything in Recall Ready
- ✓Multi-site hierarchy & dashboard
- ✓Group-level KPI rollup & audit pack
- ✓Executive reporting — quarterly
- ✓Priority support SLA
Start with Recall Watch — free, this week.
Subscribe and receive weekly TGA recall intelligence, triage guides, and governance templates. No software, no data, no obligation.