Ketryx
AI compliance platform that automates documentation and traceability for regulated medical device development
| What is it | AI compliance platform that automates documentation and traceability for regulated medical device development |
|---|---|
| Pricing | Freemium |
| Free tier | Yes |
| Platform | Web Application |
| API | Yes |
| Works with | Claude AI |
| Best for | automating FDA and EU MDR documentation for SaMD, maintaining compliance traceability during rapid iterative development |
| Domain registered | 2021 |
Data updated Aug. 1, 2026
What does Ketryx do?
Ketryx is an AI platform for regulated product development, specifically designed for medical device and other heavily regulated industries. It bridges the gap between fast software development and strict regulatory compliance by automatically generating documentation, maintaining real-time traceability, and enforcing quality management workflows. The platform is already trusted by four of the top five medical device manufacturers.
Ketryx works by connecting directly to the tools development teams already use—like Jira, GitHub, and others. As engineers write code and update requirements, Ketryx's AI generates compliant documentation on the fly, eliminating the manual reporting grind. The platform includes AI agents that continuously monitor requirements, risks, and test coverage, flagging gaps before they become compliance issues. Its real-time traceability feature creates live links between every requirement, test case, code change, and risk item, so teams can see the impact of any change instantly.
This tool is built for product teams at medical device companies, digital health startups, and any organization that must comply with FDA, EU MDR, or ISO standards. The main use cases are automating tedious regulatory paperwork, keeping quality controls in sync with rapid development sprints, and reducing the time it takes to release compliant updates. For teams tired of choosing between speed and safety, Ketryx offers a way to have both.
Key features
What makes it stand outWho is Ketryx for?
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