Cairn

FOR SAMD TEAMS

A regulatory expert in every tool you already use.

Cairn reviews your code, docs, and tickets as you work — flagging issues the moment they appear and helping you get through filing painlessly.

Request a demo See how it works
GitHub lumenvitals · PR #2
Open Regulated-path update 2 files changed
nicholasgerard @Cairn review this for IEC 62304 / FDA design-control impact before merge.
Cairn compliance review @cairn review
HIGH severity

Document impact assessment is missing

This PR changes a regulated code path but updates no tests, risk file, or validation evidence. Add the missing record — or note why none is required — before merge.

rubric · pr_review.documentation_required
Google Docs Intended Use & Indications
D
Intended Use & Indications Editing - Draft
Cairn

This intended-use claim needs a supporting clinical reference before it can be submitted.

cites FDA guidance §IV
Jira ONC board
ONC board Compliance review
ONC-214 Add dropout risk-control no trace
ONC-219 Verification protocol stale
ONC-221 Update intended-use text linked
Activity

This requirement has no verification evidence linked to it yet.

Cairn - cites requirement REQ-7
Microsoft 365 Word · controlled docs
W

How it works

Regulatory compliance that keeps up with your code.

Cairn continuously builds and reviews your regulatory package directly from your infrastructure, so your docs and evidence are always up to date.

Before

Long catch-up review meetings
Reconciling everything before a filing
One big compliance scramble

With Cairn

Flagged the moment it happens
Docs that stay current as you go
A package built from your stack

Connect your tools

Cairn works where you do.

Cairn reviews every update to your code, docs, and tasks and leaves comments and suggestions the moment something needs attention.

GitHub Pull request

lumenvitals · PR #2

Document impact assessment is missing

Cairn · rubric · pr_review.documentation_required
Google Docs Design doc

Intended Use & Indications

This intended-use claim needs a supporting clinical reference before it can be submitted.

Cairn · cites FDA guidance §IV
Jira Issue

ONC board

This requirement has no verification evidence linked to it yet.

Cairn · cites requirement REQ-7
Microsoft 365 Word doc

Word · controlled docs

This section references a retired SOP revision — update to QMS-SOP-12 rev D.

Cairn · cites controlled-document index

Verified citations

Every finding shows its work.

Cairn cites the guidance, rubric, and source artifact behind each flag, so reviewers can see why it matters before they act.

Hand-drawn tools connecting through flowing lines to a central source

Cited to the source

Every flag links to the FDA guidance, device strategy, predicate device, or standard behind it — and the exact artifact it reviewed.

Hand-drawn radar display with marked review points

Bounded by rubrics, not vibes

Checks run against versioned, inspectable rubrics — deterministic where they can be, judgment only where they must be.

Hand-drawn stack of reviewed documents with check marks

Replayable and auditable

Each finding records the source version, rubric snapshot, and run that produced it, so you can re-run it or hand it to an auditor.

01 · Get started

Start where you are.

Whether you're just starting out or getting ready to file, Cairn slots into your existing tools and processes with no migrations or tedious onboarding.

Most teams Wire it into your stack Cited findings inside the tools you already use, and a live readiness view from week one.
Late-stage teams Close the pre-filing gap A cited readiness view, prioritized gaps, and in-tool comments your team can resolve before filing.
Greenfield Start a new device right A governed workspace where traceability and readiness stay current from the first commit.

02 · Stay in control

You stay in control.

Cairn automatically drafts, flags, cites, and prepares evidence, but every controlled decision stays with a human.

  • AI never signs, approves, or releases a controlled record.
  • Comments and changes are prepared for review, never pushed silently.
  • Your team can accept, edit, or waive every recommendation.
  • Submission packages stay in review until you choose to file.

03 · Track readiness

Know what's ready.

Cairn treats compliance the way your engineering team treats code quality — as something you can run, measure, and track.

78% ready
PASS Source mirror freshness — GitHub PR synced 4m ago
PASS Requirements trace to verification evidence 31 / 31
WARN Risk control rationale needs consultant review 2 cited gaps
HELD Jira task held for human review you decide

04 · File with confidence

File when you're ready.

Cairn assembles your submission package automatically. Your team can review it and file with one click when you're ready.

  1. Assemble the package

    Cairn compiles a cited, traceable submission bundle from the evidence it has been keeping current all along.

  2. Review it together

    You and your consultant work through findings, waivers, and gaps in one place — no scavenger hunt across tools.

  3. File when you're confident

    Submit to the FDA in a click once everything passes and the people accountable have signed off.

See Cairn in action.

Tell us about your device and your tools. We'll show you how Cairn can work for your team.

Request a demo