Ketryx Gets $39 Million to Expand AI Compliance Infrastructure for Life Sciences
Ketryx, a company developing AI-native compliance platforms for regulated industries, has raised a $39 million Series B financing round. The investment was led by Transformation Capital, with participation from Lightspeed Venture Partners, MIT’s E14 Fund, Ubiquity Ventures, and 53 Stations. This brings the company’s total funding to more than $55 million. Transformation Capital’s Vinay Shah will join the board.
Headquartered in Cambridge, Massachusetts, with operations in Vienna, Austria, Ketryx was founded by CEO Erez Kaminski. The company positions itself as an enterprise-scale infrastructure layer for regulated software development, with applications across medtech and other safety-critical industries. The new funding will support global expansion, further product development, and hiring in the United States and Europe.
The raise comes as the medical device industry prepares for tightening oversight, including the U.S. Food and Drug Administration’s Quality Management System Regulation, which is set to take effect in February 2026.
The company’s platform is designed to address regulatory and documentation challenges faced by life sciences organizations as they adopt AI in product development. Ketryx automates validation, traceability, and regulatory workflows, including FDA and EU MDR documentation, aiming to accelerate release cycles while maintaining compliance standards. Reportedly, customers have seen up to a 90% reduction in documentation time and more than 10-fold faster product releases.
A central feature is the use of “validated AI agents,” which combine large language model drafting with rule-based controls, human checkpoints, and audit trails. This approach is described as neuro-symbolic: generative AI systems provide draft content, but outputs are constrained by explicit rules and recorded validation steps to create submission-ready evidence for regulatory review.
Ketryx integrates with existing development environments to avoid workflow disruption. It supports validated connections with widely used tools and infrastructure, including Jira, GitHub, GitLab, Azure DevOps, TestRail, AWS, Kubernetes, Slack, Snyk, and major programming languages such as Python, Java, and TypeScript, among other software design tools.
These integrations provide end-to-end traceability across requirements, code, tests, and risks within a regulated software development life cycle. Ketryx is also used by healthcare AI companies such as DeepHealth, Heartflow, and Aignostics.
While adoption has centered on medical devices and life sciences, the company has stated that the same evidence-driven compliance model could be extended to other regulated sectors like biopharma manufacturing, robotics, aerospace, finance, and utilities.
Topics: AI & Digital
