A governance-first layer for SaMD and clinical decision support. The IGR-001 framework, ISO 14971 alignment, TGA Class IIb pre-submission pathway, FHIR R4 + CDS Hooks integration, and the MHWA s 28 oversight overlay — packaged for hospital governance committees, SaMD developers, and regulatory-track teams.
Clinical AI and SaMD are high-stakes by definition — escalation boundaries, audit trails, override semantics, and human-oversight architecture all have to be explicit before deployment. The Fx CDSS framework gives hospital governance committees, SaMD developers, and TGA-track teams a productised oversight layer they can adopt, license, or extend.
Not tied to a single hospital, vendor, or deployment pathway. The governance layer functions as a credible oversight architecture rather than product marketing or procurement enablement.
Escalation boundaries, override semantics, human-oversight thresholds, and audit-trail discipline made explicit before deployment. Built around the G1–G5 admission gates, not generic policy templates.
Every load-bearing requirement sourced to ISO 14971, TGA SaMD guidance, FDA AI/ML transparency criteria, MHWA 2022, and the Charter Act ss 7–8 verbatim. No aggregator interpretations. Disclosure-via-changelog where the regulator updates.
Scoped fixed-fee. Named-use framework licences rather than seat licences. Tiers 1–3 self-serve via Stripe; custom memos and quarterly retainers invoiced after a scoping call. Classified as professional services.
The Fx CDSS framework stack — anchored on IGR-001 (Interim Governance Resolution) — is structured to answer the question hospital governance committees and SaMD developers actually have: which oversight controls, for which clinical risk, under which regulator. Not a policy survey; a deployment-ready architecture with citations.
Cover, governance thesis, the Three-Pillar Architecture, an IGR-001 v1.3 preview, and the full framework stack. Direct download on submit — no follow-up sales sequence, no sharing of your address.
Tier 1–2 are self-serve through secure checkout — diagnostic in your inbox within five business days. Tier 3–5 follow a scoped, fixed-fee process designed for procurement-track buyers — light on your team's time, heavy on audit-ready written deliverables.
A 30-minute call (Tier 3+) or a 1-click diagnostic purchase (Tier 1–2) to map the CDSS asset and the governance question.
Within 48 hours for custom tiers — fixed fee, fixed timeline, named deliverables. No hourly billing.
Async-first, weekly check-ins on longer engagements. Primary regulatory text traced, every requirement sourced to ISO / TGA / FDA / MHWA verbatim.
Audit-ready written deliverable, scorecard, references, framework licence (where applicable). 30-day post-engagement check-in on Tier 3+.
Diagnostic tiers are pre-paid, scoped, fixed-fee — purchased directly via secure checkout. Pre-submission, custom, and retainer engagements are scoped on a kickoff call before invoicing. Governance-buyer sales cycles are slower and bigger; the entry rung is deliberately heavier than a productised brief.
5-day audit. Single CDSS asset.
Save $1,500 vs separate purchase.
Up to 10 named users · one organisation.
3–4 weeks. Scoped before invoicing.
All tiers priced in AUD via Stripe. Tier 1 and Tier 1+ are productised; Tiers 2 and 3 are scoped on a kickoff call before invoicing. Invoices issued in AUD; GST-free (sole trader below registration threshold). Invoices issued under Leon Xu trading as Fx. Independent Advisory · ABN 47 324 504 763 — sole-trader, no Pty Ltd.
These tiers begin with a kickoff call to scope the question, the deliverable, and the timeline. Pricing is fixed before invoicing — no hourly billing.
3 weeks. One revision round.
Three months. One organisation.
The framework is written by Dr Leon Xu — a medical doctor and independent clinical-AI governance architect, working at the intersection of regulatory science, software-as-a-medical-device, and clinical-legal oversight.
The work is independent in a specific sense buyers care about: not tied to a single hospital, vendor, or deployment pathway, and not retained by a SaMD developer whose product is part of the analysis. Independence is the discipline that lets the framework state what an oversight architecture must do, separately from what any particular product can deliver.
The corpus this advisory draws from spans IGR-001 (Interim Governance Resolution), FX-CRPD-GOVERNANCE, FX-GOV-SCORECARD-001 (G1–G5 admission gates), ISO 14971 risk-management work, the TGA Class IIb pre-submission briefing v4.1, FDA AI/ML transparency criteria, and the MHWA 2022 + Charter Act oversight overlay. Every requirement is sourced to primary regulatory text before it enters a client deliverable.
IGR-001 — Interim Governance Resolution. A deployable interim governance layer for clinical AI and SaMD that has cleared CE / TGA / FDA but precedes mature institutional QMS adoption. It encodes the minimum oversight architecture an organisation needs to operate the device safely, auditably, and within MHWA / Charter / CRPD obligations. The framework is named-use licensable.
An internal QMS or governance committee operates within a single institution and its existing risk appetite. Fx CDSS supplies the independent oversight architecture these bodies adopt or extend — not a replacement for them. The framework is regulator-traceable to ISO, TGA, FDA, MHWA, and Charter text verbatim, which is structurally harder for an internal committee that is also the buyer of the device.
Exempt-class SaMD still operates in a high-stakes clinical environment, and exemption from the device pathway does not exempt the deployer from clinical-governance, audit-trail, or human-oversight obligations under hospital QMS, professional registration, or instruments like the MHWA s 28 escalation provisions. Fx CDSS targets that gap.
Tiers 1–2 are framed around the governance-diagnostic question. Tier 3 (Pre-Submission Package) and Tiers 4–5 are scoped to your specific question on a kickoff call before invoicing — typically a cross-jurisdictional regulatory positioning memo, an incident-response playbook, a board-grade audit memo, or a procurement-track risk dossier.
Professional services / advisory consulting. Each engagement is scoped, fixed-fee, and pre-paid (Tiers 1–3 via Stripe) or invoiced after a scoping call (Tiers 4–5). Invoices are issued under Leon Xu trading as Fx. Independent Advisory · ABN 47 324 504 763 — sole-trader, no Pty Ltd. ATO-compliant tax invoice on request.
Tier 1: full refund within 7 days of delivery if the diagnostic does not meet the description on this page. Tier 1+ and Tier 2: equivalent satisfaction guarantee scoped on engagement start. Tier 3 includes one revision round; further revisions scoped separately. Tier 4 includes one revision; Tier 5 includes ongoing analysis as part of the retainer scope.
Engagement details are confidential by default. NDAs are entertained for all tiers on request, and standard practice from Tier 2 onward. Aggregate insights from past engagements may inform future framework iterations, never specific client material. See the Privacy Policy for how submitted email addresses are handled.
Tier 1 is the natural entry point. If your organisation needs a deployable framework on a specific CDSS asset, Tier 1+ or Tier 2 is the right call. Pre-submission and custom engagements scoped on call.
Request a Governance Diagnostic — $2,500 AUD0009-0000-7483-3783
ABN 47 324 504 763
MELBOURNE · AU
SOLE TRADER · NAMED-USE LICENCE