In 2021, Ketryx was founded with a clear and compelling premise: to help developers in highly regulated industries release safe, high-quality software at the same speed as unregulated industries. The founders recognized that medical device and life science teams were trapped in a compliance bottleneck - burdened by manual documentation, fragmented systems, and outdated processes that slowed innovation without improving patient safety. So they built Ketryx, an AI-native compliance platform that transforms how regulated software gets developed, documented, and deployed.
Today, Ketryx is trusted by three of the world's top five medical device manufacturers to bridge the gap between development and regulatory compliance. The platform overlays existing tools like Jira and GitHub, automating documentation, creating real-time traceability, and accelerating release cycles - without disrupting established workflows. Ketryx AI Agents cut manual work by 90 percent and close compliance gaps across the entire product lifecycle. From AI/ML in medical devices to SaMD applications, Ketryx enables teams to navigate FDA, EU MDR, ISO 13485, IEC 62304, and other regulatory frameworks with confidence. By eliminating the tradeoff between speed and compliance, Ketryx is helping life science teams deliver safer products to patients faster.
