Formwork ships with its own MCP (Model Context Protocol) server, which lets your favorite AI assistants - like Claude or ChatGPT - talk to your Formwork account directly. Your AI can then search through your documents, records, CAPAs, risk items, and more, and help you get your medical device work done faster, without all the copy-pasting back and forth.
Connecting is a one-time setup. When you first connect, you'll be asked to log in with your Formwork account, and from then on, your AI tool will remember where to reach Formwork.
Setup Instructions
Pick the AI tool you use and follow the steps below.
Claude (Desktop and Web)
In Claude Desktop or on claude.ai, go to Customize → Connectors and add Formwork as a new connector, pointing it at https://app.openregulatory.com/mcp.
select "Add custom connector"
adding a Custom Connector on Claude
When you first use it, Claude will open a browser for you to log in with your Formwork account.
When you first use it, Codex will open a browser for you to log in with your Formwork account.
ChatGPT (Web and Desktop)
This also works in ChatGPT on the web and on desktop, but you'll need to enable Developer Mode first (here). Once that's enabled, you can add Formwork as an MCP server by adding it as an "App" and pointing to https://app.openregulatory.com/mcp.
adding a new App on ChatGPT
Note: We're working on shipping this as a native "app" in ChatGPT, which will make the setup much simpler — no developer mode required. Stay tuned!
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And that's it - you're connected! You can now ask your AI assistant questions about your Formwork data (like "which CAPAs are still open?") or have it help you draft and edit documents directly. As always, reach out in the customer support chat in the bottom right corner if you run into any trouble.