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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.
Enforce your SOPs exactly as written for enhanced safety or simply set up guardrails that enable your team to react and mitigate potential issues faster.
A robust traceability matrix makes it easy to verify and validate your designs and ensure conformance at all stages, reducing meetings and manual copying/pasting.
From requirements to implementation and testing, Ketryx automatically documents transactions from the source across different tools, systems, and platforms across your enterprise.
From Jira to GitHub to package managers and quality systems, Ketryx unifies your existing tools and workflows, aligning teams and simplifying collaboration.