Service ladderAU-COMM-1

A service ladder built for hospital trust
and practical adoption.

ROQAIAH's offers are structured to reduce friction: a free intelligence service, a hosted operational platform, and scoped network support — each with clear scope boundaries and no overclaiming.

Service scope boundary
Workflow and evidence — always
Clinical workflow management — excluded from SaMD regulation
Diagnosis / treatment decisions — never in scope

Recall Watch

Weekly TGA recall intelligence, triage guidance, and governance templates — delivered to your quality inbox. No software, no data, no obligation. The first conversation starter for ROQAIAH.

What you receive every week

  • Weekly TGA device recall digest — curated from TGA's recall database, classified by device class and urgency level
  • Class I recall alerts — same-day notification for death / serious injury scope devices
  • Stage 1 mandatory reporting updates — what's changed and what your obligations are
  • ROQ maturity self-assessment guide — where your hospital sits on the ROQ 1–5 maturity scale
  • RCES evidence checklist — the 19-artefact class evidence standard for verified recall closure (PDF)
  • Governance charter starter template — a role assignment and process skeleton your quality team can adapt
  • Monthly 20-minute advisory call — one call per month with the ROQAIAH team

Sample bulletin preview — synthetic data

ROQAIAH Recall Watch
Week ending 21 March 2026 · AU Edition
2 Class I alerts
CLASS I RECALL — TGA RC-2026-RN-01847
RESOLUTE ONYX Drug-Eluting Coronary Stent — Medtronic
Class III · ~1,240 units AU · Quarantine and return to sponsor
⏱ 10-day mandatory reporting obligation applies
CLASS I RECALL — TGA RC-2026-RN-01441
FreeStyle Libre 3 CGM Sensor — Abbott Medical
Class III / IVD Class 4 · ~18,400 units AU · Replace with cleared lot
⏱ 10-day mandatory reporting obligation applies
CLASS II RECALL — TGA RC-2026-RN-01791
Triathlon Knee System — Tibial Insert — Stryker
Class III · ~386 units AU · Enhanced monitoring + quarantine

Subscribe to Recall Watch — free.

No software. No credit card. No catch. Your contact details are used only to send the weekly bulletin and the occasional advisory note.

Privacy note: Your information is collected under the ROQAIAH APP-aligned privacy policy. It will not be shared with third parties. You may request deletion at any time. See privacy policy.

Submitting opens your email client to confirm the request.

Recall Ready Hosted

A single-tenant, AU-hosted recall operations platform. Every case from intake to verified closure — structured, evidence-based, and audit-ready for TGA mandatory reporting.

Platform features — MVP launch

  • Recall / adverse-event case intake with TGA reference field
  • 10-day TGA reporting countdown with auto-escalation at day 7
  • Device and inventory triage — site-level, by ward and department
  • Owner assignment and action tracking with due-date management
  • Evidence pack — upload and index against RCES artefact classes
  • Verified closure sign-off — named, timestamped, auditable
  • Exception log — reason code, risk decision, escalation path
  • KPI dashboard — TTI, TTA, VCR, open exceptions, overdue actions
  • Audit-export PDF — case summary, evidence index, closure decisions
  • Role-based access — site coordinator to group executive
  • UDI capture fields — TGA 1 July 2026 phase-in ready

Security and privacy

  • Azure Australia East — no data leaves AU
  • Zero standing vendor access — JIT only, customer-approved
  • ASD Essential Eight ML1 — documented alignment
  • APP privacy policy, NDB playbook, data-residency commitment
  • PostgreSQL row-level security — tenant isolation
  • MFA mandatory for all admin and quality-lead roles

Pricing guide

Proposal-led pricing, scoped to your hospital size, site count, and TGA reporting context.

Indicative range
AUD 30K–50K
Implementation (one-off)
AUD 12K–18K / year
Annual hosted service
Request a scoped proposal →

Recall Ready Network

For hospital groups managing recall governance across multiple sites. Consolidated executive view, group-level audit packs, and quarterly governance reviews.

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Multi-site hierarchy

Site coordinator, quality lead, group executive, and group governance roles — all with appropriate visibility and access boundaries.

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Group-level KPI rollup

Consolidated dashboard across all sites. Executive view of closure rates, open exceptions, and overdue actions — in one screen.

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Group audit-pack export

Export a consolidated PDF audit pack across all sites for board reporting, TGA submission, or ACHS EQuIP review cycles.

Network pricing is proposal-led and scoped to your group size. Ramsay Health Care (72 sites), Healthscope (38 sites), and similar groups are the primary Tier 1.5 target.

Enquire about network pricing

Not sure where to start? Start free.

Recall Watch is the no-risk first step. Subscribe, receive the weekly bulletin, and let the platform prove its value before any procurement conversation.