Document-first editor
Write requirements the way you write everything else. Mix free text, headings, and structured requirement blocks in a single document.
Requirements Management
Write requirements
like a doc.
Ship compliant
products.
Rune gives regulated product teams a document-native requirements workspace with traceability, audit history, Jira sync, and MCP access for the AI tools they already trust.
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KO
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JP
Built for regulated industries
Medical Devices & Digital Health Aerospace Automotive Defense Industrial Automation
Especially good for
Early-stage startups navigating compliance for the first time Small teams who need enterprise-grade traceability without enterprise overhead Engineers & PMs who want to write requirements, not fight their tooling Teams who believe great UX and compliance aren't mutually exclusive
Features
Requirements docs that stay connected to the work.
Rune replaces the fragmented stack of documents, Jira, and compliance spreadsheets with one tool that handles all of it — without sacrificing the writing experience.
Full traceability
Map user needs, system requirements, software requirements, risks, and tests with typed links that stay current as the product changes.
MCP-native AI integration
Connect Claude, GPT, or another MCP-compatible model to review requirements, suggest trace links, and flag gaps. Every write stays human-approved and audit-logged.
Audit trail & approvals
Every requirement change is logged — who, what, and when. Configurable review stages with e-signatures for formal sign-off.
All your compliance documents in one place
Keep your User Requirements, Software Requirements, Risk File, and more together. Baseline and compare documents when it's time to submit.
Jira integration
Link requirements to Jira epics and stories. Changes sync both ways — no double-entry.
Keep design-control evidence current as requirements evolve, with revision history, approvals, typed trace links, and submission-ready exports.
IEC 62304 ISO 13485 21 CFR Part 820 DO-178C ISO 26262
Integrations
Plugs into the tools you already use
Rune works alongside your existing stack — not as a replacement for it.
Jira
Bi-directional sync
MCP
Connect any AI model
Export
.docx · .csv · .md
SSO / SAML
Enterprise identity
GitHub
Coming soon
More integrations coming. Tell us what you need →
Pricing
Simple pricing for early regulated teams.
No enterprise sales calls. No implementation fees. No surprises.
Beta — free while we build with you
$0
Free during beta. Paid plans launch after beta — waitlist members get founder pricing.
✓ 3 documents · 100 requirements
✓ 1 writer + 1 reader
✓ MCP integration — connect any AI model
✓ Jira integration (link & sync)
✓ Approval workflows & audit trail
✓ Export (.docx · .csv · .md)
For growing teams
from$10
/user/mo
Scales with your team. Reach out to discuss what fits — no surprise invoices.
✓ Unlimited documents & requirements
✓ Unlimited team members
✓ MCP integration — connect any AI model
✓ Jira integration (link & sync)
✓ Approval workflows & audit trail
✓ Export (.docx · .csv · .md)
✓ SSO / SAML & priority support
FAQ
Common questions
Rune is a requirements management platform built for teams developing products in regulated industries — health tech, medical devices, aerospace, and defense. It's especially well suited for early-stage startups navigating compliance for the first time, small teams who need traceability without enterprise overhead, and engineers or product managers who want to write requirements without fighting their tooling. If you value good writing experience and believe great UX and compliance aren't mutually exclusive, Rune is built for you.
Enterprise tools like DOORS, Jama, Codebeamer, and Polarion are powerful, but they're often built around database workflows and heavy configuration. Rune is document-first, so requirements can live beside context, rationale, and structure while still supporting traceability, approvals, AI review, and Jira sync.
Yes. Rune is designed specifically for regulated environments. It includes configurable approval workflows, e-signatures, immutable audit trails, Design History File (DHF) management, and baseline snapshots — everything required for FDA Design Controls, ISO 13485, IEC 62304, and DO-178C submissions.
Rune connects to Jira via OAuth. You can link any requirement to one or more Jira issues. Requirement IDs are written back to Jira as a custom field or comment. When a requirement reaches "Released" status, linked Jira issues are notified. The AI Story Generator can also draft new Jira stories directly from a requirement.
Rune is MCP-native — it exposes your requirements through the Model Context Protocol so any compatible AI model can read, analyse, and suggest changes to your documents. There is no built-in AI and no vendor lock-in. Connect Claude, GPT-4, a self-hosted model, or any other MCP-compatible tool you already use. The model can draft requirement text, flag gaps, suggest trace links, and review for compliance language — but nothing is written into your documents until you explicitly confirm it. Every AI-assisted change is logged in the audit trail.
Rune is currently in pre-launch. We are working with partner teams who are using Rune on real products. Waitlist members will get early access as we open beta slots and receive founder pricing when paid plans launch.
Blog
Practical requirements writing for regulated teams.
No-fluff writing for product teams building in regulated industries.
Tooling
Jama vs. DOORS vs. Word docs: What regulated startups actually use in 2026
An honest breakdown of which requirements tool actually works for regulated startups in 2026 — and why every option has a fatal flaw until you look past the enterprise defaults.
AI
How to use MCP to supercharge requirements work — and why model choice matters
MCP lets you connect your own LLM directly to your requirements tool — and for regulated teams, that's not just a feature, it's the only responsible way to bring AI into compliance workflows.
Compliance
Requirements traceability in regulated environments: what auditors actually want to see
A practical guide to what a complete traceability matrix actually looks like for ISO 13485 and IEC 62304 — and the specific mistakes that turn auditors into adversaries.
Early access
Get early access to Rune
Join the waitlist for early beta access and founder pricing when paid plans launch.
✓ You're on the list! We'll be in touch when beta opens.
No spam. Unsubscribe any time. We send ~2 emails/month.
Contact
Talk to the team
Whether you're interested in a design partnership, have a product question, or want to discuss enterprise pricing — we read every message.