Skip to main content

Copilot

Copilot connects to Ketryx via the Model Context Protocol (MCP), bringing live compliance context directly into your AI coding environment. Access real-time traceability, AI-assisted documentation, and inline change impact assessment without leaving Copilot, allowing regulated teams to ship faster without context-switching between tools. Purpose-built for IEC 62304, ISO 13485, and 21 CFR Part 11 compliance.

Connect to Copilot

Get started

View technical documentation

Additional resources

Ketryx MCP →

Top Capabilities

Everything you need, in the space you already work.

Gain real-time compliance visibility and eliminate documentation silos with the Copilot Connector, enabling:

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, surfaced directly in Copilot via MCP.

Inline change impact assessment on every edit Before committing a change, understand its full downstream impact across requirements, risks, and test cases, without leaving your Copilot environment.

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

Enforce SOPs without disrupting developer flow Ketryx surfaces your QMS procedures and quality gates directly inside Copilot, so developers stay compliant without needing to switch tools or read policy documents.