Traceable documentation
How the AI Connector works and every tool in full, with guides, free templates and the references regulated teams ask for.
Traceable’s AI Connector (MCP) lets Claude, or another AI client that accepts a custom server URL, work inside your Traceable account under your own permissions. It can read and draft; publishing, review and e-signature stay human actions, and every change is recorded against your name. It is off until an organisation admin turns it on.
AI and integrations
Guides
Design history file (DHF)
What a DHF contains under the QMSR, how it relates to the medical device file, and how to keep it audit-ready.
Traceability matrix for medical devices
From user needs to verification, and how to keep the matrix honest between audits.
ISO 13485 document control
What clauses 4.2.4 and 4.2.5 expect, and how to meet them without the manual overhead.
IEC 62304: a practical guide
Software safety classes, key deliverables, and the role of traceability.
ISO 14971 risk management
The risk process, and why risk traceability is the part that breaks.
Using AI in a validated documentation process
How to let your team use AI on controlled documents without losing control of them.
Free templates
Evaluate and reference
Security and privacy
Where your data is hosted, how it is encrypted, and who can reach it.
FDA 21 CFR Part 11
What Part 11 asks of electronic records and signatures, clause by clause, and how Traceable meets it.
Compare Traceable
Traceable side by side with Jama, DOORS, Polarion, Word and SharePoint, Excel and more.
Pricing
Plans and prices. Reviewers and auditors are free.
ROI calculator
Estimate what your design documentation costs each year, and what changes in Traceable.
Changelog
What shipped, release by release.
Connecting an assistant with the AI Connector
Which AI assistants can connect to Traceable?
Claude on claude.ai, Claude Code, ChatGPT (developer mode) and Cursor are verified end to end. The connector is an ordinary remote MCP server, so any client that accepts a custom server URL can use it, including VS Code. Clients that only speak stdio can connect through npx mcp-remote.
Do I need anything switched on first?
Yes, two things, and both must be on. Your organisation must permit external agents, which it does by default, and your own user must be granted MCP access, which is off by default. An organisation admin turns that on. If you belong to more than one organisation, every one of them must permit it.
What can an assistant change in my account?
Drafts only. It can read projects and documents, author and edit content, build ID grids, create trace links, and search the Reference Library, all under your own permissions. Publishing, review, approval and e-signature stay human actions, and every change it makes is recorded in the audit trail against your name.
Can it see everything in my organisation?
No. It acts as you, through the same project and organisation membership as the web app. If you are not a member of a project, neither is the assistant. If your role is read-only, so is the assistant.
Is the connector included in my plan?
Yes, on every plan. It is included in Essentials, Team, Regulated and Enterprise, and available with rate limits on Free. See the pricing page for plans and prices.
See Traceable on your own documents
Import your existing requirements and see live traceability in minutes.