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It’s never been easier to become compliant with ISO 62304, 13485, 14971, 26262, IEC 61508, 21 CFR Part 11/820, the Patch Act, the EU AI Act, and the EU CRA:

With Ketryx you can use AI to automatically generate technical documentation, such as your Software Bill of Materials (SBOM), Design History File (DHF), Technical File or Type Certificate Data Sheet (TCDS), using your existing product development tools and services.

Access the complete Ketryx toolset:

• Live Requirements Traceability Matrix
• Automated evidence generation for connected development tools
• Release dashboard and management tools
• eQMS
• Connection to one Jira project
• Connection to unlimited Git repositories