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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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Sham Sokka
Chief Operating and Technology Officer for Digital Health

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Faster release cycles

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Reduction in documentation time

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Hours saved per engineer per year

AI-Driven Documentation, Real-Time Traceability, Seamless Integration, Agentic AI.

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

What our life science partners are saying

"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 supports our system of systems architecture really easily out of the box. 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. That was a huge plus."

Emre Gültürk
VP of Regulatory Affairs and Quality Systems

"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."

Christy Hardin
Director of Quality Assurance

"Ketryx has greatly improved our process reliability. The seamless integration into our workflow ensures compliance without additional effort. The automated traceability and risk management has streamlined our development process and made documentation much easier. Highly recommended for teams in regulated industries!"

Nicole Hollauf
Risk and Compliance Manager

"I used a traditional ALM in the past and it didn’t have the traceability I needed. 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 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