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
Live Webinar
SBOM and Beyond: FDA-Compliant Cybersecurity Vulnerability Management
Date:
August 8, 2024
Recorded:
August 8, 2024
Time:
11:00 am
EST
Length:
mins
Learn more
On-Demand Webinar
Making Jira Fit for 62304: Developing FDA-Compliant Software
Date:
February 29, 2024
|
Recorded:
February 29, 2024
Time:
1:00 pm
EST
|
Length:
60
mins
Transform Jira in 62304 compliance: Learn effective strategies for integrating Jira into regulated development workflows, with a focus on customization and configuration to align with IEC 62304 requirements.
Learn more
On-Demand Webinar
Git for IEC 62304: Traceability for software design, unit testing, and requirements
Date:
April 18, 2024
|
Recorded:
April 18, 2024
Time:
1:00 pm
EST
|
Length:
60
mins
This session is designed to provide an in-depth understanding of how GitHub and GitLab can be leveraged to meet the stringent requirements of the IEC 62304. Participants will learn practical strategies for tracing unit and automated tests from Git repositories to test cases and requirements, managing design controls for multiple product versions, and implementing common engineering controls in GitHub/GitLab to ensure Total Product Life Cycle (TPLC) control. We will provide practical and live examples within GitHub integrated with Ketryx. Additionally, we will explore how unified traceability across development tools, particularly between Jira and Git repositories, can streamline development processes, enhance efficiency, and support strategic objectives.
Learn more
On-Demand Webinar
Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices
Date:
July 16, 2024
|
Recorded:
July 16, 2024
Time:
1:00 pm
EST
|
Length:
60
mins
Learn more
Discover webinars
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Compliance
FDA
Generative AI
News
Product Development
Quality
Regulatory
Risk Management
Traceability
Validation
Live Webinar
SBOM and Beyond: FDA-Compliant Cybersecurity Vulnerability Management
Date:
August 8, 2024
Recorded:
August 8, 2024
Time:
11:00 am
EST
Length:
mins
Learn more
On-Demand Webinar
Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices
Date:
July 16, 2024
Recorded:
July 16, 2024
Time:
1:00 pm
EST
Length:
60
mins
Learn more
On-Demand Webinar
62304-Compliant Traceability for Automated Testing
Date:
June 18, 2024
Recorded:
June 18, 2024
Time:
1:00 pm
EST
Length:
60
mins
Learn more
On-Demand Webinar
Empowering the SDLC Process with Tools to Bridge R&D and Quality
Date:
May 15, 2024
Recorded:
May 15, 2024
Time:
12:00 pm
EST
Length:
60
mins
This session is designed to bridge the gap between QA/RA professionals and software developers, fostering a collaborative environment through improved understanding, processes, and tools.
Learn more
On-Demand Webinar
Git for IEC 62304: Traceability for software design, unit testing, and requirements
Date:
April 18, 2024
Recorded:
April 18, 2024
Time:
1:00 pm
EST
Length:
60
mins
This session is designed to provide an in-depth understanding of how GitHub and GitLab can be leveraged to meet the stringent requirements of the IEC 62304. Participants will learn practical strategies for tracing unit and automated tests from Git repositories to test cases and requirements, managing design controls for multiple product versions, and implementing common engineering controls in GitHub/GitLab to ensure Total Product Life Cycle (TPLC) control. We will provide practical and live examples within GitHub integrated with Ketryx. Additionally, we will explore how unified traceability across development tools, particularly between Jira and Git repositories, can streamline development processes, enhance efficiency, and support strategic objectives.
Learn more
On-Demand Webinar
Why building AI/ML-enabled Medical Devices requires CI/CD: A transition path
Date:
March 20, 2024
Recorded:
March 20, 2024
Time:
4:00 pm
EST
Length:
60
mins
A webinar focusing on practical steps and best practices for how to implement CI/CD in your AI/ML SaMD and medical device projects, including tool selection, process design, and overcoming common challenges.
Learn more
On-Demand Webinar
Making Jira Fit for 62304: Developing FDA-Compliant Software
Date:
February 29, 2024
Recorded:
February 29, 2024
Time:
1:00 pm
EST
Length:
60
mins
Transform Jira in 62304 compliance: Learn effective strategies for integrating Jira into regulated development workflows, with a focus on customization and configuration to align with IEC 62304 requirements.
Learn more
On-Demand Webinar
FDA Cyber Guidance: Implications for SOUP and OTS Risk Management
Date:
February 14, 2024
Recorded:
February 14, 2024
Time:
4:00 pm
EST
Length:
60
mins
Free live webinar addressing the implications of the new FDA Cybersecurity Guidance on the risk management of SOUP and OTS, with a focus on open-source software. We will cover best practices for proactively shifting cybersecurity to the earlier stages of development, often referred to as "shifting left."
Learn more
On-Demand Webinar
New FDA OTS Guidance: How to Manage Risk and Testing at Scale
Date:
January 17, 2024
Recorded:
January 17, 2024
Time:
4:00 pm
EST
Length:
30
mins
In this session, we will delve into the latest 2023 FDA guidances, with a particular focus on the use of SOUP and Off-The-Shelf Software (OTS) in medical devices and the content of premarket submissions for device software functions. Additionally, we'll explore the critical aspect of cybersecurity in medical devices, discussing quality system considerations and the content of premarket submissions. You'll gain valuable insights into best practices and tools for OTS risk assessment and mitigation at scale, as well as identifying gaps in traditional dependency management tools.
Learn more
On-Demand Webinar
Postmarket Surveillance of AI Systems: Proactive methods for identifying risk and improving product quality
Date:
December 13, 2023
Recorded:
December 13, 2023
Time:
4:00 pm
EST
Length:
30
mins
This webinar provides actionable insights on navigating the post-market regulatory landscape and creating a process focused on patient safety for AI-enabled medical devices. It will focus on best practices, emerging threats, and the role of regulatory agencies in safeguarding data privacy and ensuring device security.
Learn more
On-Demand Webinar
Transitioning to FDA’s New Premarket Submission Guidance: Impact on Quality Systems and Development Practices
Date:
Recorded:
Time:
EST
Length:
30
mins
This webinar provides large and established quality and product teams with crucial guidance information and practical steps for achieving compliance. Understand the key changes brought about by the new FDA Premarket Submission Guidance and explore the interplay between the new premarket submission guidance and other related regulations, such as eSTAR, the Software Bill of Materials (SBOM) requirement, and use of AI/ML Predetermined Change Control Plans (PCCP).
Learn more
On-Demand Webinar
The Future of Change Management for Cloud-based AI/ML Medical Software
Date:
Recorded:
Time:
EST
Length:
30
mins
The Future of Change Management for Cloud-based AI/ML Medical Software - Best practices for cloud change management - Ketryx
Learn more
On-Demand Webinar
Using a risk-based approach to comply with FDA's 21 CFR Part 11
Date:
October 11, 2023
Recorded:
October 11, 2023
Time:
4:00 pm
EST
Length:
30
mins
Join us for an insightful and comprehensive webinar on how to validate products to 21 CFR Part 11 standard using a risk-based approach (i.e.Computer Software Assurance). This event is designed to provide developers and quality/regulatory professionals with a clear understanding of the latest developments in validation and regulatory guidance from the FDA/EMA and how to implement a risk-based approach to compliance.
Learn more
No results found.
Click here
to reset filters.
.png)
.png)