ROQAIAH helps Australian hospitals receive, action, and close medical device recall notices — with the evidence trail your quality team needs for TGA mandatory reporting.
When a medical device recall notice arrives, the work has just begun. Tracking affected devices across wards and sites, coordinating actions, collecting evidence, managing exceptions, and producing a defensible closure record — that is the recall execution gap.
Recall notices come from TGA, manufacturers, and distributors — often by email, sometimes by post. Most hospitals manage the response in spreadsheets, shared drives, or email threads. There is no single record of what was done, by whom, and when.
Matching a recall notice against affected device stock across multiple wards, theatres, and stores is time-consuming work. Without a structured process, devices can be missed — and there is no audit trail to prove they weren't.
TGA mandatory reporting requires that hospitals demonstrate recall completion. An email chain is not a verified closure record. Exceptions — devices not recovered — need documented risk decisions. Most hospitals cannot produce this evidence quickly.
For events involving death or serious deterioration of a person's health related to a high-risk device, TGA Stage 1 requires a report within 10 calendar days of becoming aware. The clock does not wait for internal processes to catch up.
TGA mandatory reporting under Stage 1 places formal 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.
Automated countdown from event date, with escalation alert at day 7 to the quality lead. The most commercially critical single feature — built in from day one.
Match recall notices to affected device stock at site level. Assign by department and ward. Quantity affected, quantity accounted for — tracked in the same record.
Named sign-off by an authorised role. Timestamp. Closure decision. Exception flag where devices were 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. Store evidence where it belongs — attached to the case that needs it.
Time-to-identify, time-to-action, verified closure rate, open exceptions, overdue actions. Export a full audit-ready PDF pack for board, TGA, or ACHS EQuIP review.
A five-step workflow that gives your quality team a consistent, repeatable process for every recall event.
Three tiers designed to meet hospitals where they are — from a weekly intelligence digest to a full hosted recall operations platform.
ROQAIAH is grounded in peer-reviewed research defining the recall execution gap and the governance framework for verified completion.
Under editorial review at Globalization & Health. Citable now. Defines the 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/v1The RCES defines 19 artefact classes that constitute auditable verified recall completion. ROQAIAH's evidence-pack module is built around RCES artefact classes — connecting your workflow directly to the evidence standard.
All data is stored exclusively in Australian sovereign data centres (Azure Australia East). 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, data-residency commitment, and NDB incident response plan provided at contract stage.
Subscribe to ROQAIAH Recall Watch and receive weekly TGA recall intelligence, a triage guide, and governance templates — with no software, no data, and no commitment.