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Develop Fast.
Stay Compliant.
Integrate a risk-based approach across your medical software development lifecycle
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.
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 FDA-ready Submissions
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.