Not a vendor claim. A published framework.
ROQAIAH is grounded in peer-reviewed research defining the recall execution gap and a governance framework for verified recall completion. Citable now at the preprint DOI below.
Two papers. One governance architecture.
Both papers are under simultaneous editorial review. Both are citable now via their preprint records.
P1 — Recall Governance Paper
Closing the Recall Execution Gap — a governance framework for verified medical device recall completion
Under editorial review at Globalization & Health. Posted as a preprint 13 March 2026. Citable now. 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/v1R1 — Governance-Through-Design Paper
Trigger-based governance frameworks for digital design accountability
Under 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 — EISTRecall Closure Evidence Set (RCES)
The RCES defines the 19 artefact classes that constitute auditable, verified recall completion. It is the evidence standard that ROQAIAH's platform is built around — connecting hospital workflow to what TGA and ACHS EQuIP assessors expect to see.
ROQ Maturity Model (1–5)
A five-level governance model: from Level 1 (notice-driven, reactive) through Level 3 (structured, evidence-based) to Level 5 (realtime, AI-augmented, cross-institutional). Recall Ready is the platform path from Level 1 to Level 3.
Governance KPI metrics
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 the KPI dashboard measures.
The recall execution gap
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.
Recent Australian medical device recalls — sample dataset.
The following illustrative records are based on real published TGA and FDA recall patterns. Device names, sponsors, lot numbers, and unit counts are synthetic approximations for demonstration purposes only. Always verify against the TGA recall database for live obligations.
| TGA Reference | Device | Sponsor | Class | Recall class | Units AU | Reporting obligation | Status |
|---|---|---|---|---|---|---|---|
| RC-2026-RN-01847 | RESOLUTE ONYX Coronary Stent Medtronic Australasia | Medtronic | Class III | Class I | ~1,240 | 10-day mandatory | Open |
| RC-2026-RN-01441 | FreeStyle Libre 3 CGM Sensor Abbott Medical | Abbott | Class III / IVD 4 | Class I | ~18,400 | 10-day mandatory | Closed |
| RC-2026-RN-01791 | Triathlon Knee System — Tibial Insert Stryker Australia | Stryker | Class III | Class II | ~386 | 30-day report | In progress |
| RC-2026-RN-01653 | BD Alaris Infusion Pump — Software v12.x Becton Dickinson | BD | Class IIb | Class II | ~2,840 | 30-day report | Closed |
| RC-2026-RN-01588 | CARESCAPE B850 — ECG Lead Wire Set GE HealthCare | GE HealthCare | Class IIa | Class III Hazard | ~4,200 | Voluntary | Closed |
| RC-2025-RN-04821 | IntelliVue MX750 — Alarm System Module Philips Healthcare | Philips | Class IIb | Class II | ~1,640 | 30-day report | Closed |
| RC-2026-RN-01920 | Persona Knee System — Femoral Component Zimmer Biomet | Zimmer Biomet | Class III | Class II | ~214 | 30-day report | Open |
| RC-2025-RN-04694 | SIGMA Spectrum Infusion — Battery Module Baxter Healthcare | Baxter | Class IIb | Class II | ~3,280 | 30-day report | Closed |
Want the full research briefing?
We'll send you the P1 preprint, a plain-language summary, and the RCES artefact class overview — formatted for your quality team.