Skip to main content
No items found.
Product
Use Cases
Capabilities
Function
What is Ketryx?
Connected Lifecycle Management platform for regulated medical applications.
Read more
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.
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
Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).
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.
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.
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
Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).
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.
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
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
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.
In the News
See recent press about Ketryx's work with life sciences teams.
Certifications
See our compliance with international standards
Get started
Book a demo
Book a Demo
Get Started
Free Webinars
Using a risk-based approach to comply with 21 CFR Part 11
October 11, 2023
•
60
minutes
This browser does not support HTML video.
Webinar Resources for complying with CFR Part 11
CSA: What FDA's new draft guidance means for the future of regulated software companies
Why custom validating your development tooling is an anti-pattern
Clinical Trial Computerized Systems Regulation Review
.png)