Build AI-Enabled and Medical-Grade Software. Fast.
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Trusted by life science companies worldwide:
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The problem
Validating software is overwhelmingly complex.
Building AI-enabled products is even harder. 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. Companies building AI-enabled products spend thousands of hours validating and documenting changes to their AI models.
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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
"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
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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
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