Ketryx Secures $39M To Advance AI Compliance In Life Sciences

Life sciences teams struggle to meet strict compliance requirements while keeping up with rapid innovation. Even with advances in cloud tools and large language models, many still depend on infrastructure that isn’t designed for this fast-paced environment.

Ketryx closes this gap by automating validation, traceability, and regulatory workflows including FDA and EU MDR-compliant documentation throughout the product development lifecycle. This enables faster, safer product launches, with customers reporting up to 90% reduction in documentation time and release cycles that are over 10 times quicker.

Erez Kaminski, CEO and founder of Ketryx, shared: I’ve spent the last decade at the intersection of AI and life sciences, watching it evolve from an emerging tool to a critical application for patients. It’s now time to accelerate adoption and ensure AI is safe, reliable, and ready for regulated environments.

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Ketryx’s enterprise-grade platform is already used by three of the top five global medtech companies, multiple Fortune 500 firms, and AI-driven companies like DeepHealth, Heartflow, and Aignostics.

With adoption accelerating, Ketryx is becoming a crucial AI infrastructure layer for regulated product development. The Series B round was led by Transformation Capital, with participation from existing investors including Lightspeed Venture Partners, MIT E14 Fund, Ubiquity Ventures, and 53 Stations.

Bill Hawkins, former CEO of Medtronic and new Ketryx investor, said: In medtech long-term success depends on balancing innovation with the uncompromising demands of safety and compliance. This balance has historically been hard to achieve. Ketryx has built the infrastructure that allows both to advance together. Their ability to deliver this level of rigor at true enterprise scale is why I’m proud to support them as they shape the future of regulated software.

As part of the latest funding round, Vinay Shah, Partner and Founding Team Member at Transformation Capital will join Ketryx’s board. Shah noted that medtech teams are leading the way in leveraging AI to improve patient outcomes while maintaining the highest safety and regulatory standards, stating:

In our diligence, Fortune 500 giants and fast-growing innovators consistently praised Ketryx for proving that compliance can accelerate, rather than slow, technological progress. We believe Ketryx is defining the future of regulated infrastructure across industries and are proud to back them in their next stage of growth.

Kaminski continued: Having Transformation Capital, the pre-eminent digital health VC & growth equity firm, as our lead partner, gives us more than just capital. They understand exactly what it takes to build and scale healthcare technology companies.

With their backing and industry connections, we’re continuing our global expansion, accelerating our product roadmap, and hiring rapidly in both Boston and Austria.

Ketryx embeds real-time traceability and documentation into product development, providing zero-lag compliance that allows teams to launch safer products more quickly and at scale.

About Ketryx

Ketryx helps life science teams deliver safer products faster. Trusted by three of the top five medtech companies, its AI-powered platform automates documentation, ensures traceability and accelerates release cycles without disrupting workflows. Ketryx AI Agents reduce manual work by 90%, closing compliance gaps and enhancing speed and quality across the product lifecycle.