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Develop Fast.
Stay Compliant.
Integrate a risk-based approach across your medical software
development lifecycle
Powered by AI
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.
The first regulated software lifecycle management framework that adapts to you
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.
Design verification and validation workflows with easy to-use-traceability
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.
Automated evidence generation
From requirements to implementation and testing, Ketryx automatically documents transactions from the source across different tools, systems, and platforms across your enterprise.
Enhance your existing tools investment
From Jira to GitHub to package managers and quality systems, Ketryx unifies your existing tools and workflows, aligning teams and simplifying collaboration.