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Cursor

The Ketryx Cursor Extension brings compliance directly into your development environment. Developers access live traceability, AI-assisted documentation, and real-time quality checks without leaving their editor, so regulated teams ship faster without context-switching between tools. The extension is purpose-built for IEC 62304, ISO 13485, and 21 CFR Part 11 compliance, with full support for Ketryx natively in Cursor via the Model Context Protocol (MCP).

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Additional Resources

Ketryx MCP →

Top Capabilities

Everything you need, where you already code.

Gain real-time compliance visibility and eliminate documentation silos with the Cursor Extension, enabling you to:

Live traceability from code commits to requirements Automatically trace code changes and automated tests in Git to requirements and risks in Jira, Polarion, or any connected system. 

Automate DHF documentation from your development workflow Ketryx compiles version-controlled data from your IDE, Git history, and connected tools into submission-ready design history files.

Enforce SOPs without disrupting developer flow Ketryx embeds your QMS procedures directly into the developer workflow inside Cursor. 

Annotate source code and test files for instant traceability Use Ketryx annotation support in source code and Cucumber files to create traceable test records automatically.