Ketryx, an AI-native compliance platform for safety-critical product development, announced the beta launch of its Model Context Protocol (MCP) server. This integration 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.
According to Ketryx, the MCP server addresses a critical challenge in regulated industries: the fragmentation of product lifecycle management (PLM), application lifecycle management (ALM), and development tools. By unifying these into a knowledge graph, teams can use natural-language queries to check compliance status, identify traceability gaps, and verify release readiness without switching systems. This capability is particularly valuable for life science teams, where compliance with regulations such as FDA 21 CFR Part 820 and ISO 13485 is mandatory.
The announcement highlights that Ketryx's platform is already 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 are reported to 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. The full announcement, including downloadable images and bios, is available at the provided link.
This beta launch represents a significant step in integrating AI into regulated product development, potentially reducing time-to-market for medical devices and other safety-critical products while maintaining rigorous compliance standards.
