Agentic AI for FDA Compliance.
Safer products, faster.
Ketryx is the AI platform trusted by 3 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%.
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Trusted by leading life sciences companies
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“We are harnessing the power of AI to tackle clinical and operational challenges that arise in complex, high-volume care settings, with the aim of enabling better outcomes. Ketryx enables us to scale our innovation with quality through a single streamlined software development lifecycle, helping us expedite releases.”
Sham Sokka
Chief Operating and Technology Officer for Digital Health
Chief Operating and Technology Officer for Digital Health
10x
Faster release cycles
90%
Reduction in documentation time
600
Hours saved per developer 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 software 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.
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.
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.
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.
Ketryx is built for every team
Meet the first AI compliance platform built to move as fast as you do. Automated, real-time, FDA-ready.
What our MedTech clients are saying
“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
"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
“The fewer tools that my developers have to worry about, the better, because they should be worrying about saving people's lives with AI through our products. They don't need to be worrying about yet another tool to make sure that they can get our technology out there.”
Allan Snippen
VP of Engineering
"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
"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
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 software.
Ketryx empowers compliance leaders, R&D teams, and investors to accelerate innovation without increasing risk.
90%
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 software development, Ketryx makes regulatory approval, risk management, and AI validation seamless, automated, and always audit-ready.
What is Ketryx?
FDA-Ready Software, 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.
