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Preview Ketryx

Accelerate Product Innovation With AI

See how teams use Ketryx to keep compliance in lockstep with fast, AI-driven development.
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Trusted by four of the top five medical device companies and other AI innovators:

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

Outcomes you can expect from Ketryx

Ship Products Faster & On Time
Reduce Compliance Risk
Achieve AI Transformation Goals

Ship Products Faster & On Time

Ketryx automates traceability, documentation, and risk analysis directly from your SDLC tools. That means fewer delays during audits, faster submission readiness, and more confidence in hitting launch timelines—without sacrificing quality or safety.

Reduce Compliance Risk

Ketryx enforces quality processes and maintains real-time traceability directly within your development tools. That means complete documentation, fewer gaps, and full visibility into compliance status at every stage – so your team stays audit-ready 100% of the time.

Achieve AI Transformation Goals

Ketryx provides a risk-based AI framework with human-in-the-loop controls, so your team can integrate AI into regulated workflows without sacrificing traceability or audit readiness. That means faster adoption of AI-driven development – with guardrails to keep outputs validated and compliant.