Ketryx
About
Ketryx is a Cambridge software company that builds an AI-native compliance platform for life science and medical device teams. The platform sits on top of the development tools teams already use, automating documentation, creating traceability between requirements, risks and tests, and speeding up release cycles without disrupting existing workflows. It is built around standards such as IEC 62304, ISO 13485, GMP and FDA rules under 21 CFR Parts 820 and 11.
The company’s AI agents generate compliant documentation as software is built and help close compliance gaps, and Ketryx says they cut manual work by 90 percent. The platform also supports validating AI models and lets users query compliance data from any AI tool. Ketryx publishes resources for engineering leaders, including a case study on how Beacon Biosignals reduced its release cycle for AI and machine learning products to two weeks.
What to Know
- Four of the world’s top five medical device manufacturers use Ketryx.
- The platform is designed to let developers keep using their preferred and open-source tools.
- Ketryx is a member of the Kendall Square Association.
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