Integrate a risk-based approach across your medical software
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
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