Formwork ships with its own MCP (Model Context Protocol) server, which lets your favorite AI assistants - Claude, ChatGPT, Codex and others - talk to your Formwork account directly. Your AI can then search through your documents, records, CAPAs, risk items and more, draft new content, and help you get your medical device work done faster, without copy-pasting back and forth.
Connecting is a one-time setup. You point your AI tool at Formwork's MCP address, sign in with your Formwork account, and choose what the connection may do. From then on, your AI tool remembers where to reach Formwork and renews its access on its own.
The MCP address is always the same:
https://app.openregulatory.com/mcp
What the connection can do
A connected AI works as you: it sees exactly what you can see in Formwork, and it can only change what you can change. On top of that, every connection has an access level you pick when you connect:
- Read: the AI can look things up: query, read, search and trace anything you have access to. It cannot change anything.
- Read and write: additionally, the AI can create drafts, edit drafts, upload files and send items out for review.
Even with read and write, the AI never approves, releases, rejects, archives or deletes anything. Those steps stay with you, in Formwork. Released documents and records stay untouchable: to change one, the AI creates a new draft version, just like you would.
If your role in the company is viewer, only read access is available. If your role changes later, the connection follows your new role automatically.
Each connection belongs to one company
When you connect, the AI is bound to the company you are currently viewing in Formwork. It keeps working in that company even if you later switch to another company in your browser. This is deliberate: an AI assistant should never silently jump between companies.
To use an AI with a second company, switch to that company in Formwork first, then connect again from your AI tool. Both connections then show up side by side on your API access page (see below).
Setup instructions
Pick the AI tool you use and follow the steps below. In every case, the first use opens a browser page titled "Connect ... to Formwork": it names the app, shows the company the connection will belong to, and lets you pick read or read-and-write access. Click Connect and you are done.
Claude (Desktop and Web)
In Claude Desktop or on claude.ai, go to Customize → Connectors, choose Add custom connector, and enter https://app.openregulatory.com/mcp as the URL. Leave the OAuth client fields empty.
When you first use it, Claude opens a browser tab for you to sign in to Formwork and confirm the connection.
Claude Code
In a terminal:
claude mcp add --transport http formwork https://app.openregulatory.com/mcp
Then, inside Claude Code, run /mcp, pick formwork and choose Authenticate. A browser tab opens for you to sign in and confirm.
If you prefer editing the config file, add this to ~/.claude.json:
{
"mcpServers": {
"formwork": {
"type": "http",
"url": "https://app.openregulatory.com/mcp"
}
}
}
Codex CLI (OpenAI)
Either from the command line:
codex mcp add formwork --url https://app.openregulatory.com/mcp
codex mcp login formwork
or by adding this to ~/.codex/config.toml:
[mcp_servers.formwork]
url = "https://app.openregulatory.com/mcp"
The login step (or the first use) opens a browser tab for you to sign in and confirm.
ChatGPT (Web and Desktop)
ChatGPT needs Developer Mode enabled first (Settings → Apps & Connectors → Advanced). Once that's on, add Formwork as an app and point it at https://app.openregulatory.com/mcp. ChatGPT opens a browser tab for you to sign in and confirm.
Other tools
Any MCP client that supports remote servers over HTTP with OAuth works the same way: use https://app.openregulatory.com/mcp as the server URL and complete the sign-in when prompted. Tools that cannot sign in through a browser, such as CI pipelines or scripts, use a machine token instead: see Accessing MCP with a machine token.
Using it
Once connected, just talk to your AI as usual. A few things that work well:
- "Which CAPAs are still open, and who owns them?"
- "Summarize our software requirements for the login feature."
- "Search our QMS for anything about supplier evaluation."
- "Draft a record for today's management review; here are my notes: ..."
- "Create hazards for the following failure scenarios and link them to the existing harms."
- "Is release v1.2.0 of the device ready? Run the release readiness check."
Your AI knows which company it is connected to and tells you so if you ask. Reviewable content it creates - documents, records, design and risk items, CAPAs, change requests - appears in Formwork as a draft, with you as the author, ready for your review. Tasks, comments, folders and similar items are created directly, as if you had made them yourself.
Seeing and revoking connections
Every connection you make is listed under Settings → API access in Formwork, with the app's name, the company it belongs to, its access level, when it was connected, when it expires, and when it was last used. Revoking a connection stops it immediately; the app will ask you to sign in again the next time it needs Formwork.
Company admins see every connection bound to their company under Settings → API access in the company section, with the owner of each, and can revoke any of them.
The API access pages ask you to re-enter your password first, like the billing page does.
Good to know
- A connection is valid for a year and renews itself in the background while the app keeps using it. If it does expire, the app simply asks you to sign in again.
- The same app can appear more than once on the API access page if you connected it more than once. Each row is its own connection; revoke the ones you no longer use.
- Connections made before September 2026 are not bound to a company: they follow whichever company you are currently viewing in Formwork, until they expire. Reconnect from your AI tool to get a company-bound connection.
- Your AI's usage does not count against the weekly AI prompt budget of the in-app AI Assistant.
Something not working? See MCP troubleshooting. As always, reach out in the customer support chat in the bottom right corner if you run into any trouble.