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Discover Ketryx

Start your 30-day, all-access trial now.
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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
30 min free onboarding with customer success team included!