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

With Ketryx you can generate your Software Bill of Materials (SBOM) and Design History File (DHF) using your existing software development tools and services, creating all the needed deliverables for a 510k along with FDA’s eSTAR.

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