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Product
Use Cases
Capabilities
Function
What is Ketryx?
Connected Lifecycle Management platform for regulated medical applications.
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Solutions
Capabilities
Function
AI/ML in Medical Devices
Rapidly accelerate AI/ML software development and deployment, while staying compliant.
SaMD and Connected Devices
Reduce the complexity, time, and cost of building SaMD (Software as a Medical Device) applications.
Jira for 62304
Transform Jira into a validated, compliant platform for medical device development.
AI for Life Sciences (GxP)
Reduce the complexity, time, and cost of GxP validation for your application.
Component Reuse
Accelerate development and reuse components through a system of systems architecture.
Traceability to Automated Tests
Automatically trace automated tests in Git to requirements in Jira.
Watch a short recorded demo
AI Agents
Automate arduous tasks across your toolchain with safety-critical AI agents that keep a human in the loop.
Traceability
Automatically create a real-time requirements traceability matrix by connecting items, risks, code, and tests from all your systems.
Documentation
Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).
Enforcement
Enforce your QMS to ensure your team is following SOPs exactly as you've defined them.
SBOM
See a single consolidated view of your open-source supply chain directly from your source code.
Integrations
Integrate Ketryx with your preferred DevTools to automatically establish traceability, create documentation, and enforce your QMS.
Requirements Management
Manage and trace requirements across connected systems like Jira.
Risk Management
Control and document every risk automatically in a 14971-compliant way.
eQMS
Navigate compliance confidently with an eQMS that's interoperable with all your favorite tools.
Watch a short recorded demo
QA / RA
Enforce your QMS procedures, prevent process deviation, and ensure your software is audit-ready 100% of the time throughout the SDLC.
Dev / R&D
Keep your developers working in their preferred DevTools while maintaining compliance and traceability.
AI/ML Leaders
Reduce your documentation burden by 90% and release your AI products faster.
Watch a short recorded demo
What is Ketryx?
Connected Lifecycle Management platform for regulated medical applications.
Read more
Use Cases
AI/ML in Medical Devices
Rapidly accelerate AI/ML software development and deployment, while staying compliant.
SaMD and Connected Devices
Reduce the complexity, time, and cost of building SaMD (Software as a Medical Device) applications.
Jira for 62304
Transform Jira into a validated, compliant platform for medical device development.
AI for Life Sciences (GxP)
Reduce the complexity, time, and cost of GxP validation for your application.
Component Reuse
Accelerate development and reuse components through a system of systems architecture.
Traceability to Automated Tests
Automatically trace automated tests in Git to requirements in Jira.
Watch a short recorded demo
Capabilities
AI Agents
Automate arduous tasks across your toolchain with safety-critical AI agents that keep a human in the loop.
Traceability
Automatically create a real-time requirements traceability matrix by connecting items, risks, code, and tests from all your systems.
Documentation
Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).
Enforcement
Enforce your QMS to ensure your team is following SOPs exactly as you've defined them.
SBOM
See a single consolidated view of your open-source supply chain directly from your source code.
Integrations
Integrate Ketryx with your preferred DevTools to automatically establish traceability, create documentation, and enforce your QMS.
Requirements Management
Manage and trace requirements across connected systems like Jira.
Risk Management
Control and document every risk automatically in a 14971-compliant way.
eQMS
Navigate compliance confidently with an eQMS that's interoperable with all your favorite tools.
Watch a short recorded demo
Function
QA / RA
Enforce your QMS procedures, prevent process deviation, and ensure your software is audit-ready 100% of the time throughout the SDLC.
Dev / R&D
Keep your developers working in their preferred DevTools while maintaining compliance and traceability.
AI/ML Leaders
Reduce your documentation burden by 90% and release your AI products faster.
Watch a short recorded demo
Case Studies
Learn how AI-powered radiology company DeepHealth accelerated product development with Ketryx
Discover how AI/ML-enabled cardiovascular MedTech company HeartFlow reduced complexity by 90% with a system of systems
See how AI-powered nutrition platform Nutrino reduced SBOM documentation time by 90%
Learn how Beacon Biosignals reduced their release cycle to two weeks for AI/ML products
Discover how AI pathology company Aignostics stopped copying and pasting and accelerated their release cycle time
Explore how Foresight Diagnostics accelerated their documentation cycle by 5x
See how AI-enabled cardiovascular MedTech company Vektor Medical reduced documentation cycle time by 60%
See how Oui Therapeutics unified and accelerated their software development lifecycle
“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
"Ketryx is becoming an intrinsic part of every piece of software we build. It’s not another tool we have to use on the side to be compliant with standards; it’s just a natural way of developing high-quality software with excellence."
Helmut Hoffer von Ankershoffen
Senior VP Product and Engineering
"Vektor Medical has been through three audits, including one from a leading notified body in 2024. All auditors were amazed by the level of detail, linkage and control that is built into Ketryx. The auditors were especially impressed by the trace matrix dashboard and risk management module. Ketryx is an efficient and compliant solution for medical device software development."
Mihir Naik
Senior Director, Quality
“Ketryx empowered Nutrino to accelerate the adoption of OTS software and SOUP, ensuring confidence in our ability to proactively identify high-risk components and address potential issues early in the premarket submission cycle. This streamlined SDLC process has enabled us to deliver innovative and safe diabetes solutions much more rapidly.”
Chen Weitz
Senior Engineering Director
"I used a traditional ALM in the past and it didn’t have the traceability I needed, especially tracing from my test executions and results. It also created duplicate work since I needed to go update my work there every time I completed a task. 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 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
“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.”
Alexander Chan
VP of Analytics and Machine Learning
“Overall we’ve been very happy relative to our previous workflow. Ketryx lets us get a lot more granular and more specific in terms of defining the configuration items. It maps much better onto our software development workflow and processes.”
Alec Winograd
VP of Engineering
Pricing
Resources
Documentation
Access Ketryx's extensive product documentation.
Blog
Learn about regulated medical device software development.
Support and FAQs
Customers submit tickets here for all product needs.
Webinars
Hear from experts on medical device software development.
White Papers
Take a deep dive into regulated software development.
About
Company
Learn the origin story of Ketryx and how we got to where we are today.
Why Ketryx
Understand why regulated software teams choose Ketryx.
Careers
Learn about our team and opportunities to join us.
Newsroom
See recent press about Ketryx's work with life sciences teams.
Certifications
See our compliance with international standards
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White Papers
Regulated Development Resources
FDA software regulations and compliance education designed for developers, builders, and software quality professionals
A Playbook for Transforming Jira to Support IEC 62304 Compliance
To bridge the gap between Jira’s capabilities and IEC 62304 requirements, Ketryx offers integration that extends Jira’s functionality to support compliance. Learn how Ketryx transforms Jira into a powerful tool for IEC 62304-compliant software development.
Download
IDC Spotlight: Connected Life-Cycle Management Streamlines Software Development for Medical Devices
This Spotlight Paper from leading technology analyst IDC explores how Connected Lifecycle Management (CLM) is transforming software development for regulated industries.
Download
FDA Cyber Guidance and the Software Supply Chain: A Playbook for Shifting Left
Discover how to navigate the complex landscape of cybersecurity for medical devices with this comprehensive guide.
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FDA PCCP Compliance Guide
Learn more about the FDA's guidance on PCCPs (Predetermined Change Control Plans) for AI/ML-enabled medical device software.
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Modernizing FDA-Grade Software Development with Validated DevOps
Discover how Validated DevOps can help you develop software faster while staying compliant.
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A Guide To Implementing CI/CD in Your AI/ML SaMD Projects
Learn why CI/CD is crucial for AI/ML SaMD development and how you can transition your organization to CI/CD.
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FDA Predetermined Change Control Plan (PCCP) Template
This template is designed to assist organizations in developing a comprehensive plan to manage and assess modifications to Machine Learning Device Software Functions (ML-DSFs) in medical devices.
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Discover Why Traceability Doesn't Have to Be So Hard
Explore why traceability has traditionally been so challenging in medical software development and why cloud and AI only add to the complexity.
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Regulatory Pathways
Learn about the different approval pathways possible, and how to find the one that works best for you.
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IEC 62304 Compliance Checklist
Companies can take a few key steps to simplify their FDA compliance journey and start building medical software. Use this checklist to go through these key steps.
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SaMD Regulatory Requirements
Learn which regulations and standards are necessary to meet compliance for Software as a Medical Device.
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The Cost of Quality
What is quality and why can it make creating products more expensive? What is the cost of creating high quality products?
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JavaScript Static Analysis Tools for Medical Devices
The focus of this paper is on software applications written in JavaScript that meet the Food and Drug Administration’s (FDA) regulatory definition of a medical device.
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Inside the FDA Regulatory Process
Former FDA software systems safety expert, Paul Jones, shares his insights.
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