# Traceable Docs

> Traceable Docs (the product is called Traceable) is requirements traceability and document control software for regulated product teams: one secure, AI-connected workspace for every document, review and signature. Write in a familiar, document-style workspace while Traceable keeps every requirement linked, every change controlled and every approval recorded, so your evidence is audit ready the day you need it.

Canonical: https://traceabledocs.com//

## Who it is for

- Medical device teams working to IEC 62304, ISO 13485 and ISO 14971: https://traceabledocs.com//solutions/medical-devices
- Medical device startups that want to start small: https://traceabledocs.com//solutions/medical-device-startups
- Independent regulatory and QA consultants: https://traceabledocs.com//solutions/regulatory-consultants
- Quality and regulatory teams: https://traceabledocs.com//solutions/quality-and-regulatory
- Systems engineers decomposing and tracing requirements: https://traceabledocs.com//solutions/systems-engineers
- Defence programs working to ISO 9001, AS9100D, MIL-STD-882E and DO-178C: https://traceabledocs.com//solutions/defence

## Key capabilities

- Document templates: start every document from a structured template built for the standard you work to.
- Review and approval: reviews, deadlines and electronic signatures happen inside the document, and the audit trail writes itself as you go.
- Version control: see who changed which requirement and when, compare any two revisions, and roll back without losing the record.
- Live traceability: requirements, risks and tests stay connected as documents change, and a broken link surfaces before an auditor finds it.
- Structured content: requirements, risks and tests are data you can filter, link and report on.
- Any document type: set up any document type, template and ID prefix, so the tool follows your process.
- AI Connector (MCP): connect Claude or another AI assistant to your account, under your own permissions. https://traceabledocs.com//mcp.md
- Pilot plan: run a real project in Traceable at no cost, with our team alongside, measured on your documents: https://traceabledocs.com//contact?type=sales&topic=pilot

Traceable is built for teams working to standards such as IEC 62304, ISO 13485 and ISO 14971. It is aligned with what those standards expect of documentation. It does not itself make an organisation compliant or certified.

## Pricing

Free for one author. Paid plans are priced per author per month on monthly billing: Essentials US$35, Team US$64, Regulated US$119. Enterprise is priced by quote. Reviewers and auditors are free on every plan. New organisations start with a 30-day trial of Team. Full pricing: https://traceabledocs.com//pricing.md

## Links

- Pricing: https://traceabledocs.com//pricing
- AI Connector: https://traceabledocs.com//mcp
- Documentation: https://traceabledocs.com//docs
- Requirements management software: https://traceabledocs.com//requirements-management-software
- Compare with other tools: https://traceabledocs.com//compare
- Get started: https://traceabledocs.com//get-started
- Contact: https://traceabledocs.com//contact
- Site index for agents: https://traceabledocs.com//llms.txt