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.
When a recall notice arrives, the work has just begun — tracking devices across wards, coordinating teams, collecting evidence, managing exceptions, and producing a defensible closure record.
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.
Matching a notice to affected stock across wards and sites is time-consuming. Without a structured process, devices can be missed — with no audit trail to prove otherwise.
TGA mandatory reporting requires demonstrated recall completion. An email chain is not a verified closure record. Exceptions need documented risk decisions.
For events involving death or serious deterioration of health related to a high-risk device, Stage 1 requires a TGA report within 10 calendar days of becoming aware.
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 a hospital workflow tool for receiving, triaging, actioning, and closing recall and adverse-event cases — with evidence management, KPI reporting, and audit-export built in.
TGA reference, device class, event type, date received, and reporting obligation flag — captured in a structured record from day one.
Automated countdown from event date. Escalation alert at day 7 to the quality lead. The most commercially critical single feature — built in from launch.
Match recall notices to affected device stock at site level. Assign by department and ward. Quantities tracked in the same record.
Named authorised sign-off, timestamp, closure decision, and exception flag for devices not recovered — a defensible record your team can produce on request.
Upload and index supporting documentation against the Recall Closure Evidence Set (RCES) artefact classes. Evidence stored where it belongs — attached to the case.
Time-to-identify, time-to-action, verified closure rate, open exceptions, overdue actions. Export a full audit-ready PDF for board, TGA, or ACHS EQuIP review.
Five steps. One repeatable process. An evidence trail at every stage.
Three tiers designed to meet hospitals where they are — from a weekly intelligence digest to a full hosted recall operations platform.
Subscribe and receive weekly TGA recall intelligence, triage guides, and governance templates — no software, no data, no commitment required.
Weekly TGA device recall intelligence, triage guidance, and governance templates — delivered directly to your quality inbox. Start building your recall-readiness posture without any software or data commitment.
Recall Watch is the Tier 0 foundation of the ROQAIAH service ladder. It builds the relationship and the vocabulary before any software is involved.
No software. No data. No obligation. Cancel any time. Your contact details are used only to send the weekly bulletin and the occasional advisory note.
Recall Ready gives your hospital a hosted platform, structured evidence management, and the KPI dashboard your board expects to see.
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.
The Recall Ready feature set is built around one goal: giving your team an auditable, repeatable process for every recall event — from the moment a notice arrives to verified closure.
| Feature | TGA alignment | Priority |
|---|---|---|
| Recall / adverse-event case intake Structured form: TGA reference, device class, event type, date received, reporting obligation flag | Stage 1 trigger identification | P0 — Launch |
| 10-day TGA reporting timer Countdown from event date, auto-escalation at day 7, alert to quality lead | Stage 1 — 10 calendar days | P0 — Launch |
| Device / inventory triage Site-level inventory match, affected device quantity, department / ward assignment | Closure evidence pre-requisite | P0 — Launch |
| Owner assignment and action tracking Assign responsible person, due date, action type, sub-tasks, status | Operational workflow management | P0 — Launch |
| Evidence pack — RCES artefact aligned File upload per action, metadata tagging, artefact class labels | RCES evidence class mapping | P0 — Launch |
| Verified closure sign-off Named sign-off by authorised role, timestamp, closure decision, exception flag | RCES core — verified completion | P0 — Launch |
| Exception log Devices not recovered, reason code, risk decision, escalation path | Mandatory for closure defensibility | P0 — Launch |
| KPI dashboard TTI, TTA, verified closure rate, open exceptions, overdue actions | ROQ maturity measurement | P0 — Launch |
| Audit-export pack PDF report with case summary, evidence index, action log, closure decisions, exceptions | TGA submission & internal audit | P0 — Launch |
| Role-based access control Site coordinator, quality lead, group exec, read-only, vendor-JIT | APP 11 security controls | P0 — Launch |
| UDI tracking module Capture and verify Unique Device Identifiers at recall intake | TGA UDI phase-in 1 July 2026 | Phase 2 — M5–7 |
| Multi-site group dashboard Consolidated executive view, rollup KPIs, group-level audit-pack export | Network tier enablement | Phase 2 — M5–7 |
| TGA notice auto-import Scheduled integration with TGA recall database | Reduces notification lag | Phase 2 — M6–8 |
ROQAIAH Recall Ready is designed around device-event records, not patient records. This architectural decision reduces Privacy Act obligations, simplifies procurement, and accelerates hospital sign-off.
All data is stored exclusively in Australian sovereign data centres. No standing vendor access — support is JIT, customer-approved, and fully logged. ROQAIAH is designed around device-event records, not patient records — minimising Privacy Act obligations from the ground up. APP privacy policy, AU data-residency commitment, ASD E8 ML1 alignment evidence, and NDB incident response plan provided at contract stage.
We'll prepare a proposal tailored to your site count, device mix, and TGA reporting context. No pressure — start with a scoping call.
ROQAIAH is not a general quality management system. It is purpose-built for hospital quality and biomedical engineering teams who need to demonstrate recall compliance under TGA mandatory reporting obligations.
Recall governance touches three layers of the hospital. ROQAIAH is designed so each role sees exactly what they need — and the evidence trail supports all three.
The operational owner. Responsible for receiving notices, coordinating teams, collecting evidence, and managing the closure process end to end.
The device expert. Responsible for inventory matching, device identification, quarantine and return logistics, and technical sign-off on affected device status.
The oversight layer. Needs confidence that the hospital's recall posture is defensible — and a report they can take to the board, the TGA, or an ACHS EQuIP assessment.
Ramsay Health Care (72 sites), Healthscope (38 sites), Luye Medical, St Vincent's Private — multi-site groups with a group quality function and site-level biomedical teams. The Network tier is designed for this segment.
Independent acute hospitals with 50–350 beds, a quality and safety function, and direct TGA mandatory reporting obligations. Tier 1 single-site is designed for this segment.
Day surgery and specialist procedural facilities. High use of Class III implantable devices. Often under-resourced for recall management relative to their device risk exposure.
NSW Health, Queensland Health, SA Health — state-level networks with more complex procurement requirements. IRAP assessment path and ASD Essential Eight documentation are required. Timeline: Year 2.
Start with a 20-minute introductory call. We'll walk through your current recall process and show you exactly where ROQAIAH adds the most value.
ROQAIAH is grounded in peer-reviewed research defining the recall execution gap and a validated governance framework for verified recall completion — citable now.
The ROQAIAH framework is grounded in peer-reviewed research under simultaneous editorial review. Both papers are citable now via their preprint records.
Under editorial review at Globalization & Health. Posted as a preprint 13 March 2026. Citable now in all outreach contexts. Defines the recall execution gap, Recall Closure Evidence Set (RCES), ROQ maturity model (levels 1–5), and governance metrics (TTI, TTA, VCR, EB, RRD, EoC).
↗ doi.org/10.21203/rs.3.rs-9098866/v1Under review at Environmental Innovation and Societal Transitions (EIST). Defines trigger-based governance and accountability-through-architecture — the design logic that underpins how ROQAIAH structures governance obligations into the platform itself.
Under review — EISTThe RCES defines the 19 artefact classes that together constitute auditable, verified recall completion. It is the evidence standard that ROQAIAH's platform is built around — connecting hospital workflow directly to what TGA and ACHS EQuIP assessors expect to see.
A five-level staged governance model: from Level 1 (notice-driven, reactive) through Level 3 (structured, evidence-based) to Level 5 (realtime, AI-augmented, cross-institutional). ROQAIAH Recall Ready is the platform path from Level 1 to Level 3. Levels 4–5 are the protected Healthchain architecture.
Six metrics operationalise the ROQ framework: Time-to-Identify (TTI), Time-to-Action (TTA), Verified Closure Rate (VCR), Evidence Burden (EB), Recall Readiness Differential (RRD), and Extent of Compliance (EoC). These are the metrics your KPI dashboard measures.
The gap between a recall notice being issued and a hospital being able to demonstrate, with auditable evidence, that every affected device has been identified, acted on, and closed out appropriately. P1 defines it. ROQAIAH closes it.
We'll send you the P1 preprint, a plain-language summary, and the RCES artefact class overview — formatted for your quality team.
A 20-minute call with the ROQAIAH team. We'll walk through your current recall process and show you exactly where the platform adds value — using a synthetic dataset that matches your hospital type.
We listen. How do recall notices arrive? Who coordinates the response? What does your quality team use today?
We show the case intake, 10-day timer, evidence pack, KPI dashboard, and audit-export — using synthetic data from a comparable hospital type.
Recall Watch subscription, scoping engagement for a Tier 1 proposal, or a direct proposal discussion. You choose the pace.
"Your data stays in Australia. We operate AU-hosted infrastructure with zero standing vendor access. We start with governance templates — no patient data required in Tier 0."
Version 1.0 [DRAFT — NOT FINAL] · Effective date: [TO BE SET] · ABN: [TO BE ASSIGNED]
ROQAIAH Health Governance Pty Ltd (ACN [to be assigned], ABN [to be assigned]) ("ROQAIAH", "we", "us", "our") is committed to protecting the privacy of individuals in accordance with the Privacy Act 1988 (Cth) and the Australian Privacy Principles (APPs). This policy explains how we collect, hold, use, and disclose personal information.
ROQAIAH collects the following categories of personal information:
Minimum-PID design: The Recall Ready platform is designed around device-event records, not patient records. ROQAIAH does not require, request, or store patient health information (PHI) as part of its standard service model.
We use personal information to provide and improve our services, to communicate with you about your account or enquiry, to send the Recall Watch bulletin (with your consent), and to comply with our legal obligations. We do not use personal information for any purpose inconsistent with the purpose for which it was collected.
All personal information collected through ROQAIAH's services is stored on infrastructure located in Australian data centres (Microsoft Azure Australia East, with backups to Azure Australia Southeast only). ROQAIAH does not transfer personal information outside of Australia without your consent or unless required by law. This commitment is stated in all customer contracts.
We do not sell, rent, or share personal information with third parties for commercial purposes. We may disclose information to trusted subcontractors (such as Microsoft Azure) who assist us in providing our services — all of whom are contractually bound to protect your information. We may disclose information if required by law.
We take reasonable steps to protect personal information from misuse, interference, loss, and unauthorised access. Our security controls are aligned to the ASD Essential Eight Maturity Level 1. We operate a zero-standing vendor access model — our team accesses production data only through Just-in-Time (JIT) access sessions, which are customer-approved and fully logged.
ROQAIAH is subject to the Notifiable Data Breach (NDB) scheme under the Privacy Act 1988 (Cth). In the event of an eligible data breach, we will notify affected individuals and the Office of the Australian Information Commissioner (OAIC) within 30 days of becoming aware of the breach, as required by law.
You have the right to request access to the personal information we hold about you, and to request corrections. To make a request, contact us at [privacy@roqaiah.com.au — to be set]. We will respond within 30 days.
Privacy Officer: ROQAIAH Health Governance Pty Ltd · [Address — to be set on entity formation] · Email: [privacy@roqaiah.com.au — to be set] · Phone: [to be set]
Version 1.0 [DRAFT — PLACEHOLDER ONLY] · Effective date: [TO BE SET]
By accessing or using ROQAIAH's website or services, you agree to be bound by these Terms and our Privacy Policy. If you do not agree, do not use the services.
ROQAIAH provides hospital workflow software for the administration and management of healthcare facility recall and adverse-event processes. The services are not intended to diagnose, screen, treat, or make recommendations about individual patients or clinical conditions.
All intellectual property in the ROQAIAH platform, framework, and associated materials (including the ROQ-AIAH-STD-1000 standard, RCES artefact classes, and Healthchain architecture) remains the property of ROQAIAH Health Governance Pty Ltd and its principals. No licence to reproduce or distribute is granted without express written consent.
[To be finalised by legal counsel — standard SaaS limitation of liability clause, consistent with the MSA. Will cap liability at fees paid in the preceding 12 months for most claims.]
These Terms are governed by the laws of [State / Territory — to be confirmed on entity formation], Australia.
For terms enquiries: [legal@roqaiah.com.au — to be set]. For commercial enquiries, request a demo or proposal via the demo page.