Sold by: KetryxÂ
AWS Free Tier
Build FDA-compliant software | Automate audit-grade documentation and traceability. Agile SAFe, Part 11, 13485, 62304, 14971, QMS
Overview
Ketryx is an AI-native compliance platform that transforms how life science teams build, validate, and release products. Trusted by three of the world's top five medical device manufacturers, Ketryx's AI Agents interoperate with existing tools like Jira, GitHub, and Polarion to automate documentation, create end-to-end traceability, and accelerate release cycles-without disrupting existing workflows. AI Agents reduce manual work by up to 90% and close compliance gaps, helping teams deliver safer, higher-quality products faster.
Highlights
- AI across your DevTools: Ketryx AI Agents interoperate with your DevTools like Jira, GitHub, GitLab, and AWS-analyzing work as it happens and capturing compliance context automatically. Developers stay in flow while AI handles the regulatory lift.
- AI-driven QMS enforcement: Ketryx AI Agents act as quality enforcers across all connected systems. They coach developers in real time, flag deviations, and automatically enforce QMS processes directly in your preferred DevTools.
- AI-powered traceability: Ketryx generates a living traceability matrix-continuously mapping requirements, risks, and tests. AI Agents detect gaps, propose missing links, and suggest risk controls before auditors ever see the file.
Details
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Support
Vendor support
Email support services are available from Monday to Friday.
support@ketryx.comÂ
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