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Query regulated medical-device lifecycle data — requirements, tests, risks, traceability.
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The Ketryx MCP server connects a regulated product-development workspace — medical device and life-sciences lifecycle data governed by FDA 21 CFR Part 11, IEC 62304 and ISO 13485 — to Claude, ChatGPT and any MCP-compatible agent. Anthropic lists nine tools. Every one reads. Nothing among them signs, approves or edits a compliance artifact.
Verified connector
Listed by Anthropic as a partner connector in its Connectors Directory.
Connection checked by Agentman on .
Anthropic states this reflects the level of review a connector received, not a security audit.
Tool names from Anthropic's directory listing. This server requires sign-in, so we could not read tool descriptions or parameter schemas.
docs.ketryx.com/reference/ketryx-mcp-server, returns HTTP 307 to a GitBook login at app.ketryx.com/auth/gitbook. Every path on that host does, including llms.txt and robots.txt. This page is built from Ketryx's public marketing, press and support content instead.tools/list response and cannot report readOnlyHint or destructiveHint for any tool. The read-only classification is ours, derived from the names and from Anthropic's Read permissions field, not the server's own declaration.scopes_supported, and the Stytch authorization server advertises only OpenID identity claims plus offline_access. Nothing at the OAuth grant separates one kind of access from another. Since the listed surface is entirely read, there is no routine-versus-irreversible boundary to be missing — but there is also none to rely on if the surface grows.full_access is unresolved. It appears in the OpenID discovery document and not in the OAuth authorization-server metadata on the same host. We could not determine whether the MCP server requests it or what it gates.No tool among the nine Anthropic lists carries an approve, sign, submit or transition verb. Every name is a read: find, get, list, resolve or search. In a regulated quality system an electronic signature is a legally significant act under FDA 21 CFR Part 11, so this absence is the single most important fact about the connector, and we treat it as this listing's state rather than an architectural guarantee.
Not with the nine listed tools. None carries a create, update, write, delete or exclude verb, and Ketryx's directory listing records its permissions as Read. Requirements and test records mostly live in Jira, Polarion or Azure DevOps, and Ketryx documents editing and excluding items through those systems or its own web UI, not through this connector.
None that separate reading from writing. The server's RFC 9728 descriptor declares no scopes_supported at all, and its Stytch authorization server advertises five OAuth scopes that are OpenID identity claims plus offline_access. The OpenID discovery document on the same host adds a sixth, full_access, which names a breadth no listed tool exercises.
Ketryx announced the MCP server as a beta on 31 March 2026 and still routes prospective users through an access-request form rather than a self-serve toggle. Its press release describes the beta as open to organizations building regulated products across medical technology, digital health and robotics. Expect to request access before the endpoint will authenticate you.
Your design history file, effectively. The tools reach configuration items, requirements, test records, risks, version settings and item change history across Jira, Jama, GitHub, TestRail, Polarion and Azure DevOps. Ketryx documents that item change history records who changed what and when, which is the Part 11 audit trail an FDA inspector would examine.
Yes, and that is the point of the connector. Retrieved records enter your AI client's context. Ketryx documents that its own optional in-platform AI features route only to zero-data-retention endpoints, contractually barring providers from storing or training on the data. That control covers Ketryx's internal calls, not the separate client you connect over MCP.
No. We searched Ketryx's full 774-page public content mirror, 272,281 words, on 2026-08-23 and found zero occurrences of any of the nine tool names. The documentation URL Anthropic publishes redirects to a login wall. So the nine names come from Anthropic's directory with no vendor list to check them against.
Yes. A read-only surface removes the risk of an agent altering a record, not the risk of it reporting a gap that is not there or missing one that is. Ketryx documents that custom fields are absent from its standard API responses, so an agent may reason from an incomplete record. Verify a release-readiness answer against Ketryx before acting on it.
llm.ketryx.com, nominated by ) · retrieved 2026-08-23initialize to https://app.ketryx.com/api/mcp returned HTTP 401 with a www-authenticate header naming resource_metadata; RFC 9728 descriptor at https://app.ketryx.com/.well-known/oauth-protected-resource; authorization server metadata and OpenID discovery at https://pleasant-bridge-4023.customers.stytch.com (2026-08-23) · retrieved 2026-08-23Connect Ketryx once and your agents call these tools on their own: on a schedule, in a workflow, with nobody at the keyboard.