Infrastructure
Powered by Complear OSTM
A unified operating system bridging the gap between agile AI development and rigid global standards.
THE INTELLIGENCE LAYER
01
Semantic Regulatory Core
Complear OS ingests global regulatory frameworks and transforms them into a continuously updated compliance knowledge base.
Key Capabilities
- Multi-domain parsing: EU AI Act, FDA, ISO 13485 (MedTech), ISO 26262 (Automotive), DO-178C (Aerospace)
- Semantic mapping across domains, languages, and versions
- Real-time updates as standards evolve
- Machine-interpretable compliance primitives for downstream layers
Outcome
Teams build against live, executable regulation, eliminating outdated standards and manual interpretation errors.
THE VERIFICATION LAYER
02
Continuous Compliance Engine
A real-time verification layer integrated directly into development and deployment workflows.
Key Capabilities
- Compliance-aware CI/CD execution
- Automated evidence capture (logs, configs, traces)
- Runtime telemetry monitoring
- Drift detection across models, code, and infrastructure
Outcome
Non-compliance is identified before it reaches production, reducing certification delays and eliminating last-minute firefighting.
THE ATTESTATION LAYER
03
Sovereign Trust Infrastructure
A cryptographic assurance layer designed for high-security and regulated environments.
Key Capabilities
- Zero-knowledge proofs over compliance events
- Verify compliance while guarding your intellectual property
- Offline and air-gapped verification support
- Secure evidence packaging for auditors and regulators
Outcome
Compliance becomes provable, portable, and secure, even under export controls or adversarial operating conditions.
Compliance as Code
Compliance lives where your product lives — in the repository
Complear OS turns regulatory obligations into versioned, executable artifacts. Requirements bind to code, tests, and reviews; evidence is harvested from your pipeline; releases gate on live compliance state — for any product, in any regime.
# complear.yaml — compliance manifest, versioned with the product
product: infusion-pump-fw
regimes: [EU-MDR, IEC-62304, ISO-14971]
requirements:
REQ-114:
clause: ISO 14971 §7.1
risk: R-031 (dosage overflow)
verify:
- test: tests/safety/dosage_limits.spec.ts
- review: design/hazard-analysis.md
gate: release # block release if evidence is stale
Requirements bind to engineering artifacts
Every clause maps to requirements, and every requirement points at the code, tests, and design reviews that satisfy it. Traceability is a property of the repository, not a spreadsheet.
Releases gate on live evidence
The verification gate runs like any CI check: stale evidence or untraced changes block the release before they ever reach an auditor — or a patient, a cockpit, a power grid.
Any product, any regime
The manifest is regime-agnostic: swap EU-MDR for DO-178C or the EU AI Act and the same enforcement loop applies — one infrastructure from medical devices to autonomous systems.
The Agentic Platform
Agents that enforce compliance — not just monitor it
A coordinated fleet of specialized agents runs the compliance loop continuously: watching regimes, mapping obligations, harvesting evidence, auditing the trace graph, and compiling regulator-ready dossiers. Enforcement is the default; humans approve the exceptions.
Regulatory Watch Agent
Monitors every tracked regime for amendments and guidance updates, then flags exactly which of your requirements are impacted — before the transition window closes.
▸ EU AI Act Art. 6 amended → 3 requirements flagged
Mapping Agent
Decomposes standards clauses into concrete obligations and binds them to your architecture, so new components inherit their regulatory surface automatically.
▸ IEC 62304 §5.1 → 12 obligations mapped to architecture
Evidence Agent
Harvests proof from CI runs, test suites, and reviews as you build — keeping every requirement's evidence fresh instead of reconstructed before audits.
▸ test_run #4821 captured → REQ-114 evidence ✓
Verification Agent
Continuously audits the trace graph for gaps, stale links, and untraced changes — and opens actionable tasks before an auditor ever finds them.
▸ trace coverage 98.6% → 2 gaps opened as tasks
Attestation Agent
Compiles the full trace into sealed, regulator-ready technical documentation on demand — submission becomes a build artifact.
▸ technical file compiled · sha256:9f2c…a41b
Humans stay in command
Agents act under explicit policy: they can block, flag, and prepare — but waivers, sign-offs, and submissions always require human approval. Enforcement with accountability.
complear-os · agent activity
live[Regulatory Watch Agent] regulatory delta detected · EU AI Act Art. 6(2) amended
[Mapping Agent] impact analysis · 3 requirements touched in infusion-pump-fw
[Verification Agent] REQ-218 verification stale → release gate armed
[Evidence Agent] ci/test_run #4821 ingested · 14 artifacts linked ✓
[Verification Agent] trace graph re-audited · coverage 98.6% → 100% ✓
[Attestation Agent] dossier delta compiled · ready for human sign-off