Ketryx, the AI-native compliance platform for safety-critical product development, today announced the beta launch of its Model Context Protocol (MCP) server. This enables AI tools such as ChatGPT, Claude, and Copilot to securely access live compliance data from Ketryx, allowing both people and AI agents to build regulated products with full compliance awareness.
The emergence of MCP reflects a broader shift in how regulated products get built. AI tools and agents are increasingly embedded in product development workflows and are writing code, generating documentation, and running analyses, yet these AI systems operate without compliance awareness. Ketryx MCP bridges that gap, bringing compliance intelligence directly into AI-powered workflows so that both people and AI agents can build products compliantly.
With access to an organization's full compliance context, AI coding agents produce higher-quality specs, test cases, and code from the start, while Ketryx governs the output through its approval and traceability framework. Teams can now check compliance status, identify traceability gaps, verify release readiness, and use AI tools in ways that are compliant within their R&D workflows without switching between multiple systems.
As AI adoption across engineering teams accelerates, compliance workflows remain fragmented across PLM, ALM, and development tools like Jira, GitHub, and TestRail that don’t talk to each other. Engineers and quality teams spend significant time manually reconciling traceability and documentation before a release, a burden that only grows as AI accelerates the rest of the product development workflow.
Ketryx MCP connects these disparate systems through a unified knowledge graph, enabling teams to gather intelligence by asking natural-language questions such as, “Is this release ready for deployment?” and “Are there traceability gaps between requirements, code, and tests?”
“AI agents are already embedded in how engineering teams build products. But until now, those agents had no awareness of safety and compliance,” said Erez Kaminski, CEO and Founder at Ketryx. “Ketryx has allowed people to build safe products at scale. Our MCP extends that same capability to AI agents. Now every participant in your development workflow, human or AI, operates within full knowledge of your QMS, your traceability graph, and so much more.”
Unlike general-purpose AI tools, Ketryx grounds every AI response in each organization’s validated compliance data and quality management procedures. The neuro-symbolic platform pairs large language model reasoning with a deterministic rules layer tied to each team’s procedures and quality system. This ensures answers are provably bound, auditable, and specific to the regulations teams actually work under. With MCP, this compliance intelligence extends directly into teams’ preferred AI tools, so regulated organizations can adopt AI across their product development workflows without compromising the standards they are required to follow.
The beta program for Ketryx’s MCP is now open to organizations developing regulated products across medical technology, digital health, and robotics. To learn more, read about the Ketryx MCP or register for an upcoming live walkthrough: https://www.ketryx.com/learn/webinars/register/mcp-2026.
Ketryx transforms the product lifecycle of life science teams to deliver safer products, faster. Trusted by four of the world’s top five medical device manufacturers, its AI-native compliance platform overlays existing tools to automate documentation, create traceability, and accelerate release cycles—without disrupting existing workflows. Ketryx AI Agents cut manual work by 90 percent and close compliance gaps, elevating speed and quality across the entire product lifecycle. For more information, visit www.ketryx.com.
SOURCE: Ketryx