FDA, EU MDR, & ISO Compliance Software & Application Lifecycle Management (ALM) - Ketryx
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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:
“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
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Faster release cycles
%
Reduction in documentation time
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.
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 life science partners are saying
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.
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 product development, Ketryx makes regulatory approval, risk management, and AI validation seamless, automated, and always audit-ready.
What is Ketryx?
FDA-Ready 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.