MEDICAL DEVICES
Governance-native AI infrastructure for device manufacturers and diagnostics equipment vendors
Constitutional RuntimeWho this is for
Medical device manufacturers, in-vitro diagnostics vendors, imaging and monitoring equipment producers, connected-device and remote-monitoring platform teams, and post-market surveillance groups deploying AI where a wrong answer touches design history, a quality-system record, a complaint file, or a post-market signal. ETHRAEON provides constitutional runtime posture. Regulatory clearance for any device or software function remains the manufacturer's responsibility.
- Class I, II, and III device manufacturers and their software teams
- In-vitro diagnostics vendors and reagent-and-instrument suppliers
- Imaging, monitoring, and connected-device platform organizations
- Quality, regulatory affairs, and post-market surveillance groups
- Contract manufacturers and design-history-file custodians
Capability surface
Constitutional runtime
The PRAXIS 7-Gate pipeline enforces governance on every AI action. It stops when unsure. Evidence is mandatory. Defaults deny rather than guess. Design-history reasoning, complaint triage, and quality-system workflows inherit this posture by construction.
Design history and QMS evidence
Every AI action against a design-history file, risk-management record, CAPA entry, or quality-system artifact records to a tamper-evident, SHA-256 hash-chained evidence store. Regulatory review, internal audit, and post-market inquiry trace by default, not retrofit.
Post-market surveillance posture
Complaint intake, adverse-event signal aggregation, and field-safety-notice drafting pass through the runtime with provenance and human-authority checkpoints preserved. Signals carry the sealed chain from raw report to reviewed disposition.
Labeling and IFU integrity
AI-assisted labeling, instructions-for-use drafting, and translation review carry sealed provenance for language pairs, version state, and human authority. Deterministic guardrails prevent silent scope drift on regulated text.
Supplier and component provenance
Component qualification records, supplier attestation, incoming-inspection results, and non-conformance signals carry the same evidence chain as the AI actions that reason over them. Sustainment and inspection surfaces reach one authoritative record.
Sovereign deployment
On-premise, private-cloud, or hybrid sovereign deployment for manufacturers that cannot expose design-history, personnel, or complaint content to a vendor cloud. Evidence store and constitutional runtime operate inside the boundary you already validate.
Where governance meets the device lifecycle
Device manufacturers compound risk when AI is retrofitted onto quality systems and post-market processes. ETHRAEON is designed for the classes of decision where design integrity, regulatory posture, and audit trail all matter.
- Design and risk-management reasoning. AI-assisted design-input analysis, hazard-and-harms reasoning, and verification-and-validation drafting carry sealed provenance: input tags, model version, guardrail state, and human authority for edge-case escalation.
- Complaint and CAPA workflows. Complaint triage, investigation drafting, CAPA support, and effectiveness-review synthesis pass through the constitutional runtime with regulatory posture enforced by construction.
- Post-market signal review. Adverse-event aggregation, trending, and field-action drafting record the reasoning chain from raw complaint to reviewed disposition.
- Labeling and translation review. Regulated-text drafting, translation review, and version reconciliation carry version-anchored provenance from source language to authorized market release.
Mapped ETHRAEON products
The operational problem in medical devices is proving, under EU MDR and IVDR and the FDA quality system, that a design-history, CAPA, or post-market determination was governed: obligations identified, mapped to the QMS, approved by a named authority, and replayable. Three ETHRAEON products map directly onto that problem and run as one governed workflow. The concrete deliverable is a device-documentation evidence receipt plus an obligations-to-controls map.
Compliance Engine
Live runtime, available by subscription. For a manufacturer it captures the EU MDR and IVDR, FDA device quality-system (21 CFR Part 820 and ISO 13485-aligned), and post-market-surveillance obligations that bind a design-history, risk-management, CAPA, or complaint action and maps each to the QMS. It records the obligation, the obligation-to-policy-to-control mapping, and each evidence linkage through the governed runtime; every evidence linkage returns a SHA-256 evidence node. It runs EU AI Act risk-class detection, GDPR data-lineage tracing, cross-border data-movement flags with provenance, and configurable rule packs per jurisdiction, and exports a regulator-ready audit log. It never issues, claims, or implies certification; sign-off remains a human authority act.
Governance Dashboard
Live runtime, available by subscription. For the quality and regulatory function it surfaces live enforcement state across design-history and quality-system workflows for regulatory review and internal audit. It is the composition and observability layer over the governed-decision products: a live constitutional-rule enforcement panel, per-model and per-agent policy-state visibility, a preventative halt log with rationale, per-tenant rule scoping, and a read-only board or audit-committee view, white-label on request. It reads governed-runtime state and never overrides a constitutional or authority boundary.
GENTHOS 3.0
Refinement, quality-assurance, and governance-safe output engine. For the device-documentation claim it refines and quality-assures the governance-safe artifact before a reviewer or auditor sees it; it never makes the conformity determination. It executes only after upstream routing, within constitutional bounds, and writes each refinement step to the append-only evidence chain. It never performs the sovereign decision, the valuation, or the arbitration; SOC 2 is self-certified and ISO 42001 and EU AI Act alignment are readiness-mapped, not certified.
Deliverable: a device-documentation evidence receipt plus an obligations-to-controls map for a design-history, CAPA, or post-market-surveillance action. It maps against EU MDR and IVDR, FDA device quality-system expectations (21 CFR Part 820 and ISO 13485-aligned), and post-market-surveillance obligations, and it is produced by the governed runtime at the moment of the action, not reconstructed under review pressure afterward.
The conformity and clinical-safety determination stays with the manufacturer qualified function; the runtime produces and governs the evidence.
Proof surface
ETHRAEON runs its own operations under constitutional governance. 300 plus production surfaces, 700 plus governance directives executed and evidenced, a hash-chained evidence store, and a substrate registry that reports live status. The infrastructure is the demonstration.
Engagement
Device engagements start with a governance briefing scoped to your product portfolio, quality-system posture, and current AI deployment surface. The briefing produces a written architecture assessment and a deployment path proposal. From there: pilot inside a validated quality system, evidenced production integration, or sovereign private-cloud install.
Portfolio anchors
ETHRAEON is a constitutional runtime and evidence control layer. Portfolio posture: 16 filed U.S. provisional applications / 75 technical specifications / 9 families. Public claims are calibrated. AGI-class and ASI-class positioning is architectural, not an achievement claim. This surface describes commercial capability posture. It is not a representation of any regulatory clearance, marketing authorization, or intended use for a specific medical device. Manufacturers retain full responsibility for regulatory compliance of their own products.