AI is being embedded in everything from robotic surgery to AI-driven diagnostics, but each innovation multiplies the paperwork required by regulators. The culprit is the crushing weight of compliance documentation, which can eat up 50–80% of development time.
Austria-based Ketryx believes it’s cracked the problem. The company just raised a $39 million Series B, led by Transformation Capital, to expand its AI-native compliance platform that automates traceability, validation, and documentation in real time.
With its new funding, Ketryx plans to accelerate its AI agent roadmap, automating even more compliance workflows, deepen integrations, expand globally, hiring engineers and regulatory experts in Boston and Vienna.
Ketryx promises “zero-lag compliance” by generating regulatory paperwork automatically as code is written. That allows MedTech companies to release new products and updates every one to two weeks, rather than every one to two years, while still meeting stringent FDA requirements under standards like IEC 62304.
Already, three of the world’s top five MedTech companies are using the platform. Customers include Medtronic, Beacon Biosignals, which achieved FDA clearance for two AI products with two-week release cycles, RadNet/DeepHealth, and Heartflow, which simplified its architecture by 90% while serving 400,000+ patients.
