Ketryx is an AI-native compliance platform that automates validation, traceability, and regulatory workflows across the life sciences product development lifecycle. The platform produces FDA/EU MDR-ready documentation and overlays existing tools to automate documentation without disrupting workflows. Customers include three of the top five global medtech companies, several Fortune 500 organizations, and AI-driven firms such as DeepHealth, Heartflow, and Aignostics. Users report up to a 90% reduction in documentation time and over 10x faster release cycles. With the new funding, Ketryx plans to continue global expansion, accelerate its product roadmap, and hire rapidly in Boston and Austria. The company positions itself as an enterprise-grade AI infrastructure layer that helps regulated teams balance safety, compliance, and faster innovation. Ketryx builds connected application lifecycle management software aimed at companies creating FDA‑regulated software and AI‑based applications in the life sciences. Its platform overlays product development tools to create a real‑time, traceable single solution that connects items, risks, code, and tests. The system automates documentation and enforces standard operating procedures across connected systems to improve quality and compliance. By linking development artifacts and processes, Ketryx aims to reduce time to market for regulated applications. The company is led by Founder and CEO Erez Kaminski and plans to use new funding to accelerate product development and commercial expansion.

Total raised

$53M

Funding rounds

2

Latest round

Series B

Latest activity

Sep 2025