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AI for regulated product development. Safer products, faster.

Ketryx is the AI platform trusted by 4 of the top 5 medical device manufacturers to bridge the gap between development and regulatory compliance. Teams stay in their preferred tools, while Ketryx AI generates traceability and documentation—reducing documentation burden by up to 90%.

Trusted By:

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One Validated Platform, Total Compliance.

Regulated industries have always faced a trade-off: move fast or stay compliant. Ketryx eliminates the choice by seamlessly connecting product development with regulatory requirements. Innovation can finally move at the pace of technology—without sacrificing safety, quality, or compliance.

AI generated compliant documentation as you build.

Ketryx's ability to generate technical documentation on the fly saved us countless hours. Instead of manually compiling reports, we effortlessly produced comprehensive, up-to-date documentation with minimal effort.

Alexander Buesser

Head of Product and Engineering

Agentic AI powers continuous compliance

Ketryx gives us a repeatable quality process, saves us time, and helps us release faster while also ensuring that we have controls for all risks.

Nicole Hollauf

Risk and Compliance Manager

Track every requirement, risk, and test without effort.

The automated traceability and risk management has streamlined our development process and made documentation much easier. Highly recommended for teams in regulated industries!

Enforce quality processes without slowing down.

The Ketryx platform has significantly enhanced our operational efficiency by streamlining processes that previously required manual duplication for Quality-related documentation.

Christy Hardin

Director of Quality Assurance

Ship FDA-compliant software in record time.

Ketryx updates itself as I’m working in Jira and GitHub. This tighter integration into our current tools helps us be more productive and release faster.

Aaron Berlin

SVP Development and Engineering

Ketryx is built for every team

Meet the first AI compliance platform built to move as fast as you do.

Ensure compliance is built in, not an afterthought.

"We were able to migrate our monolithic ecosystem into a single project and break it down into a desired state just within a couple of days. Ketryx delivered that because it was designed to scale."

Emre Gültürk

VP of Regulatory Affairs and Quality Systems, Heartflow

AI keeps workflows agile while meeting the strictest FDA standards.

"Our engineers are still working with the same speed and agility, only now they are operating in a regulated environment. With Ketryx, compliance processes just run in the background."

Roman Bugaev

CTO, Flo Health

Validate AI models and automate documentation in one place.

"Ketryx helps us remain agile while delivering high-quality, AI-driven products."

Alex Chan

VP of Analytics and Machine Learning, Beacon Biosignals

What our life science partners are saying

"Ketryx enables asynchronous development of our product and the documentation required to stay compliant, move fast, and make high-quality AI products at scale."

Ian Hanson

SVP, Engineering

"When I compare Ketryx AI to out-of-the-box tools like Gemini or ChatGPT for regulated product development, Ketryx consistently gives me the best answers. What makes Ketryx AI different is that it’s operating inside the project itself. It’s reading the actual design history, requirements, and context of the product, rather than pulling generic answers from the web and hoping they apply."

Lucas Fernandez

Director, Medical Devices

"Ketryx has been revolutionary for our team. Documentation used to take more than a month. Now we click a button and have the documents. I want to continue development with a much higher release frequency, and Ketryx is a major enabler for this strategy."

Eldad Klaiman

Subchapter Lead, navify Digital Pathology

"With Ketryx, we automated and streamlined far more than expected. Work that would have taken us a year was completed in just 90 days because of their expertise, partnership, and platform. Had we chosen another provider, our confidence and our timeline would have looked very different."

Tsimafei Savitski

Chief Legal and Compliance Officer

"The Ketryx platform has significantly enhanced our operational efficiency by streamlining processes for Quality-related documentation. This optimization has not only expedited the release process but also delivered measurable value to both our Quality and Engineering teams. Ketryx’s expertise and dedication to customer success have made them an indispensable partner."

Nicole Hollauf

Risk and Compliance Manager

"Ketryx has allowed us to channel our hardware and software engineers’ existing set of development, testing, and documentation practices directly into the generation of compliant documentation with minimal additional burden. This has allowed us to remain agile while delivering high-quality products."

Alex Chan

VP of Analytics and Machine Learning

The Challenge

Traditional compliance is a bottleneck

Manually tracking requirements, documenting changes, and enforcing regulations takes months instead of minutes. Ketryx AI removes the manual burden, letting your team focus on what matters—building great products.

Ketryx empowers compliance leaders, R&D teams, and investors to accelerate innovation without increasing risk.

10x

Faster than the old way

Build at the Speed of Tech

Ketryx doesn’t replace your development tools. It orchestrates them.

By embedding compliance into modern product development, Ketryx makes regulatory approval, risk management, and AI validation seamless, automated, and always audit-ready.

Compliant Products, Without the Hassle

Contact us to see how Ketryx and agentic AI can accelerate your development time by up to 10X while keeping your team audit-ready.