Document Generation
Auto-generated from your code, infrastructure, and integrations. Your architecture doc is always current because it's built from the architecture.
Regulatory compliance that
keeps up with your code.
Cairn continuously builds your regulatory strategy and documentation directly from your codebase and dev tools to help you get and stay compliant.
$200K typical consultant spend
Included AI + expert review
18 mo to first submission
Weeks to submission-ready
40+ documents, manually maintained
Auto-generated from your source of truth
From zero to submission-ready.
Get compliant in weeks, not months — without slowing down your team.
01 ONBOARD
Map your regulatory pathway
Answer a few questions about your device and intended use. Cairn identifies your submission strategy and builds your compliance workspace.
510(k)De NovoSaMDClass II
02 CONNECT
Connect your stack
Cairn watches commits, tickets, and docs across your tools — no manual uploads, no busy work.
- GitHub repos and pull requests
- Jira tickets and epics
- Cloud infrastructure and CI/CD
03 BUILD
Put compliance on autopilot
While your team ships product, Cairn updates your DHF, risk analysis, and traceability matrix in real time. No backfilling, no catch-up sprints.
Design History FileRisk AnalysisTraceability MatrixSoftware ArchitectureSOUP Analysis
04 SUBMIT
Submit with one click
Generate your 510(k) or De Novo package ready for FDA review. Expert-reviewed and formatted for eSTAR expectations.
- eSTAR-formatted output
- Expert regulatory review included
- Readiness tracked in real time
05 MONITOR
Ship without regulatory anxiety
Cairn monitors post-market changes and alerts you when something needs regulatory attention. Stay compliant as your product evolves.
Design ChangesPost-Market SurveillanceCAPA TrackingQMS Updates
Real-time visibility into every requirement.
Cairn treats compliance the way your engineering team treats code quality — as something you can run, measure, and track.
The compliance stack your team deserves.
Cairn comes with everything your regulatory strategy needs — integrated, automated, and expert-backed.
Compliance Engine
Continuous monitoring with real-time pass/fail against live system state. Not a checklist — a test suite.
Change Detection
Traces the impact of every code change through your entire regulatory document dependency graph. Nothing drifts.
Quality Events
CAPA, deviations, design changes. Full 21 CFR Part 11 electronic signatures. Audit trail for everything.
Submission Workflow
eSTAR packaging, readiness tracking, section-by-section assembly. Your 510(k) builds itself.
GitHub + Jira Native
Your dev infrastructure is the source of truth, not a separate system.
Expert Review Built In
Work directly with regulatory experts through the platform. Not a handoff — a collaboration.
Post-Clearance Monitoring
Compliance doesn't end at submission. Cairn tracks post-market changes and keeps your QMS current.
Complete Audit Trail
Every decision, every change, every review — timestamped, attributed, and ready for inspection.
Build the device.
We'll handle the rest.
Request early access to Cairn.
Built for SaMD teams. FDA 510(k) and De Novo.