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Build traceable FDA-compliant software, fast, with preferred DevTools.

Trusted by medical software companies worldwide:
The problem

Validating software 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.

Medical device software teams use Ketryx to reduce complexity, develop fast, and stay compliant.

Ketryx speeds development of medical software with the first self-tracing, self-documenting, and self-enforcing SDLC.
Introducing Ketryx

The only developer-first connected lifecycle management platform built to use your preferred DevTools

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.
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Enforce QMS processes

Ketryx acts as a quality agent across all connected systems, coaching and enforcing your QMS processes directly in your preferred DevTools.
Explore enforcement

Establish traceability

Ketryx creates a real-time traceability matrix by overlaying product development tools and connecting all items, risks, code, and tests.
Explore traceability

Automate documentation

Ketryx generates Part 11-compliant evidence and a submission-ready DHF from the work being done in your preferred DevTools.
Explore documentation

Release faster

Release safer software faster using automation to generate documentation, establish traceability, and streamline processes.
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How we integrate your tools

Capabilities built for regulated software development

Change management

Automate change control processes and trace changes across the SDLC.
See how it works


Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).
Explore Documentation


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


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


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 MedTech companies choose Ketryx so they can develop fast and stay compliant.


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.
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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.
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What our MedTech clients are saying

Foresight Diagnostics
"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
Aaron Berlin
SVP Development and Engineering
Rook Quality Systems
"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
Andrew Wu
VP of Medical Software
Oui Therapeutics
"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
Alec Winograd
VP of Engineering
Beacon Biosignals
"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
Alex Chan
VP of Analytics and Machine Learning
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