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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.
Traceability to Automated Tests
Automatically trace automated tests in Git to requirements in Jira.
Component Reuse
Accelerate development and reuse components through a system of systems architecture.
GxP
Reduce the complexity, time, and cost of GxP validation for your application.
Watch a short recorded demo
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.
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.
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.
Traceability to Automated Tests
Automatically trace automated tests in Git to requirements in Jira.
Component Reuse
Accelerate development and reuse components through a system of systems architecture.
GxP
Reduce the complexity, time, and cost of GxP validation for your application.
Watch a short recorded demo
Capabilities
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.
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.
Watch a short recorded demo
Case Studies
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
See how Oui Therapeutics unified and accelerated their software development lifecycle
Explore how Foresight Diagnostics accelerated their documentation cycle by 5x
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
White Paper
Modernizing FDA-Grade Software Development with Validated DevOps
Discover how Validated DevOps can help you develop software faster while staying compliant.
Download
White Paper
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.
Download
Template
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.
Download
eBook
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.
Download
White Paper
Regulatory Pathways
Learn about the different approval pathways possible, and how to find the one that works best for you.
Download
Checklist
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.
Download
White Paper
SaMD Regulatory Requirements
Learn which regulations and standards are necessary to meet compliance for Software as a Medical Device.
Download
White Paper
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?
Download
White Paper
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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eBook
Inside the FDA Regulatory Process
Former FDA software systems safety expert, Paul Jones, shares his insights.
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