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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
Connection to one Jira project
Connection to unlimited Git repositories
30 min free onboarding with customer success team included!