Build traceable FDA-compliant products, fast, with preferred DevTools and AI.
Trusted by life science companies worldwide:
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The problem
Validating products has become overwhelmingly complex.
Quality and R&D teams struggle to manage and validate across countless DevTools, open source libraries, versions, and vulnerabilities, leading to slower time to market and increasing costs.
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Ketryx's AI-powered FDA regulatory compliance software speeds development of medical devices.
Life science teams use Ketryx to reduce complexity, develop fast, and stay compliant with the first self-tracing, self-documenting, and self-enforcing SDLC.
FDA Regulatory Compliance Software
The only developer-first connected lifecycle management platform built to use your preferred tooling
Stay in modern DevTools
Ketryx deeply and natively integrates with best-in-class DevTools like Jira, GitHub, GitLab, and AWS, so your developers don’t need to leave their preferred tools.
See integrationsEnforce QMS processes
Ketryx acts as a quality agent across all connected systems, coaching and enforcing your QMS processes directly in your preferred DevTools.
Explore enforcementEstablish traceability
Ketryx creates a real-time traceability matrix by overlaying product development tools and connecting all items, risks, code, and tests.
Explore traceabilityAutomate documentation
Ketryx generates Part 11-compliant evidence and a submission-ready DHF from the work being done in your preferred DevTools.
Explore documentationRelease faster
Release safer software faster using automation to generate documentation, establish traceability, and streamline processes.
Watch Recorded DemoHow we integrate your tools
Capabilities built for regulated development
Change management
Automate change control processes and trace changes across the SDLC.
See how it works
Documentation
Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).
Explore Documentation
Traceability
Ketryx creates a real-time traceability matrix by overlaying product development tools and connecting all items, risks, code, and tests.
Explore traceability
Version control
Use the release dashboard to quickly compare changes between versions.
See how it works
Automated testing
Connect and trace automated tests to requirements, risk controls, and specifications.
How we trace to automated tests
SBOM
See a single consolidated view of your open-source supply chain directly from your source code.
Explore SBOM
Vulnerability management
Automated vulnerability detection helps you quickly evaluate risk.
Explore Vulnerability Management
Integrations
Connect your preferred DevTools into a single, traceable SDLC.
See available integrations
Risk management
Proactive monitoring identifies potential risk and security vulnerabilities.
Explore Risk Management
Who is Ketryx for?
Quality professionals and R&D leaders at top MedTech companies choose Ketryx's FDA compliance software so they can develop fast and stay compliant.
Quality
Quality isn’t just a department – you’re the heart of the entire product lifecycle. Quality professionals choose Ketryx to infuse quality into every stage of the product lifecycle, ensuring quality at the source and compliance throughout the process.
Learn more
R&D
Ketryx enables agile development processes and automation to control all changes and documentation with ease, letting you focus on what you do best: building software.
Learn moreTestimonials
What our MedTech clients are saying
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“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
"We are harnessing the power of AI to tackle clinical and operational challenges. The Ketryx software 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
“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 is a must-have tool for developing medical device software. This is the only tool out there that allows bi-directional synchronization between Ketryx and all other software development tools such as Git tools, Jira, test management tools, cloud instances, etc. Schedule a demo with the Ketryx team NOW!"
Andrew Wu
VP of Medical Software
"Ketryx has been a lifesaver for the creation of properly validated medical device software. Our product and engineering teams can work seamlessly between Jira and Ketryx. The Ketryx team has also been extremely responsive in providing support, whether that means helping us understand existing workflows better or improving them based on our use cases and feedback."
Alec Winograd
VP of 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
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