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 is the requirements tool that regulated teams actually want to use. Document-first editing, Jira-native integration, and AI that understands regulated workflows — built for health tech, aerospace, and medical devices.
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KO
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Built for regulated industries
Medical Devices & Digital Health Aerospace Automotive Defense Industrial Automation
Features
Everything regulated teams need. Nothing they don't.
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
Cross-document traceability with typed links.
AI-native workflows
Built-in AI agents for requirement review and trace suggestions. Expose your data to any AI via MCP — humans confirm before anything is committed.
Audit trail & approvals
Every requirement change is logged — who, what, and when. Configurable review stages with e-signatures for formal sign-off.
Design History File
Keep your DHF in one place — URS, SRS, Risk File, and more. 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.
Rune is designed to make compliance feel natural — not like a tax on your workflow. Teams working under these standards can meet their documentation and traceability requirements without friction.
IEC 62304 ISO 13485 FDA Design Controls 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
Claude / MCP
AI agent integration
Word Export
Formatted .docx output
SSO / SAML
Enterprise identity
GitHub
Coming soon
More integrations coming. Tell us what you need →
Pricing
Simple, founder-honest pricing
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.
✓ Unlimited requirements & documents
✓ AI agents (Requirement Creator, Regulatory Reviewer)
✓ Jira integration (link & sync)
✓ Approval workflows & audit trail
✓ Export to Word (.docx)
✓ Up to 5 team members
○ E-signatures & baselines (Phase 2)
○ Custom AI agents (Phase 2)
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 for product managers, systems engineers, QA leads, and regulatory affairs teams who need compliance-grade workflows without giving up a good writing experience.
Existing enterprise tools (DOORS, Jama, Codebeamer, Polarion) have strong compliance models but terrible writing experiences — they feel like database UIs, not documents. Rune is built document-first, so requirements live in a real document alongside context, rationale, and structure. It also ships with native AI workflows and Jira integration that enterprise tools have only bolted on as afterthoughts.
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's AI agents always output suggestions, never direct edits. You review every suggestion and confirm before anything is applied. All AI-generated content is flagged in the audit trail with the source agent and the human who accepted it.
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
Requirements management, practically
No-fluff writing for product teams building in regulated industries.
Tooling
Jama vs. DOORS vs. Word docs: What regulated startups actually use in 2026
Enterprise tools offer strong compliance models but brutal UX. Lightweight tools feel great but fail audits. Here's an honest breakdown of where each tool wins — and where the market has a gap.
AI
How to use Claude for requirements work — a practical guide for regulated teams
AI tools can dramatically speed up requirement elicitation, writing quality checks, and traceability — if you prompt them correctly for a compliance context. 25 prompts that actually work.
Compliance
Requirements traceability in regulated environments: what FDA and ISO auditors actually want to see
Traceability is the difference between passing your first audit and failing it. Here's what a complete requirements traceability matrix looks like for a 510(k) submission — with examples.
Early access
Get early access to Rune
Join the waitlist and be first in line when we open beta slots. You'll also get founder pricing when paid plans launch — locked in forever.
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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.