Compiler spine
Source -> tests -> findingsArtifact versions, source bindings, provider snapshots, source maps, citations, and package manifests stay linked.
Regulatory compiler for SaMD teams
Regulatory compiler for SaMD teams.
Cairn turns source artifacts, work-system snapshots, strategy, and regulatory constraints into typed, cited, replayable compliance signals.
Start with read-only audit evidence, then graduate to gated workflow assistance after source, security, and legal posture are approved.
CI-for-compliance
Runs on product changePRs, Jira changes, document updates, imports, and scheduled package checks can produce stable results and cited logs.
Write posture
Would-write firstExternal comments and tasks require trigger envelopes, deterministic validation, output records, idempotency, and replay.
Human floor
No AI approvalsAI can propose, draft, detect, explain, route, and prepare evidence; humans retain signatures and final dispositions.
How it works
From source mirror to reviewable evidence.
Cairn fits around the work systems your team already uses, then makes source freshness, traceability, package gaps, and human decisions visible.
Define device strategy and source posture.
Map intended use, submission path, source systems, corpus boundaries, and what Cairn is allowed to mirror.
Watch the systems where work already happens.
Cairn records artifact versions, external source bindings, provider snapshots, sync health, and stale-source warnings.
Run compliance checks as product work changes.
The compiler evaluates catalog checks against mirrored evidence, strategy, and traceability endpoints.
Route findings and package gaps to human owners.
Suggested updates, comments, and package sections move through explicit review queues before any controlled decision.
Keep readiness visible without replacing your QMS.
Cairn shows freshness, changes, failures, approvals pending, and replay history while source systems remain authoritative.
CI-for-compliance
Compliance checks should feel runnable.
Results cite source versions, mirror freshness, test definitions, and review posture so teams can rerun, waive, or route them with evidence.
Launch paths
Start where the evidence risk is real.
Cairn is launching around bounded pilot paths that keep source authority, human decisions, and external writes explicit from the first conversation.
Read-only corpus audit
Late-stage SaMD teams that need independent visibility into De Novo, 510(k), or internal audit evidence without changing source systems.
controlled docssigned PDFsspreadsheetsGitHub/Jira exports
Output: Cited findings, traceability gaps, stale-source warnings, and a replayable audit report.
GitHub, Docs, and Jira workflow buildout
Teams that want compliance checks to run near product work while comments, tasks, and suggested updates remain gated would-writes.
PR snapshotsGoogle Docs commentsJira issuestrigger envelopes
Output: Review queues, prepared external outputs, validator records, and idempotent replay artifacts.
New device (greenfield)
New product teams that want source mirror, strategy, compliance tests, and human review queues wired before evidence starts drifting.
intended useregulatory pathsource policyreview roles
Output: A governed compiler workspace for source freshness, traceability, findings, package readiness, and human decisions.
Product surfaces
A governance view over the compliance signal layer.
Cairn does not need to become the authoring home for every artifact. It watches, compiles, routes, and records the evidence needed for regulated work.
Hybrid source mirror
Defensible mirrored state for GitHub, Jira, docs, uploads, and historical package exports, including freshness and provenance.
Compliance test catalog
Versioned deterministic, evidence-check, AI-judgment, and manual-review checks that users can inspect before trusting outputs.
Traceability graph
Candidate and confirmed links between requirements, risks, controls, tests, evidence, claims, and package sections.
Gated external outputs
Comments, draft tasks, and suggested document updates are prepared as would-writes with validation and replay records.
Human review queues
Quality, regulatory, consultant, and engineering owners keep final authority over approvals, releases, signatures, and risk.
Evidence packages
Cited, replayable package views for audits, consultant review, signoff preparation, and submission readiness discussion.
Security and regulatory trust
Human authority stays explicit.
Cairn can propose and prepare evidence, but controlled quality decisions remain bounded by human review, policy, permissions, and audit records.
Data posture
Production exports default to metadata, hashes, artifact IDs, and redacted excerpts.
Trace redaction events and evidence package manifests
Security
Support access requires approval, scoped sessions, and audit events.
Support access grants, sessions, and auth events
Source integrity
Every finding cites the source version, mirror freshness, and run context it depended on.
Source artifact versions, sync states, and compiler run artifacts
Regulatory authority
Catalog fixtures and AI judgments route to consultant or human review until formally approved.
Catalog version, rubric snapshots, and review queue events
| Boundary | Posture |
|---|---|
| Approvals, release, and signatures | AI never signs, approves, releases, or closes controlled quality records. |
| External writes | Would-writes require trigger envelopes, deterministic validation, output records, idempotency, and replay. |
| Final risk and submission decisions | Humans retain final risk acceptance and final submission-required determinations. |
| Customer systems of record | Cairn mirrors source systems and routes work back to them; it does not force day-one QMS replacement. |
Build the device. Cairn handles the compliance signal layer.
Request read-only audit fit reviewPilot waitlist
Read-only audit first.
Pilot conversations start with corpus scope, security posture, source-of-truth boundaries, and read-only audit fit.
Request a fit review
SaMD founders, quality leaders, and regulatory consultants
Your request is stored for fit review only and never shared.