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live 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:  
45
 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
live webinar

Making Jira Fit for 62304: Developing FDA-Compliant Software 5/29/24

Date:  
May 29, 2024
  |  
Recorded:  
May 29, 2024
Time:  
1:00 pm
 EST
  |  
Length:  
45
 mins
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.
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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.
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Compliance
FDA
Generative AI
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Product Development
Quality
Regulatory
Risk Management
Traceability
Validation
Making Jira Fit for 62304: Developing FDA-Compliant Software 5/29/24Making Jira Fit for 62304: Developing FDA-Compliant Software 5/29/24
live webinar

Making Jira Fit for 62304: Developing FDA-Compliant Software 5/29/24

Date:  
May 29, 2024
Recorded:  
May 29, 2024
Time:  
1:00 pm
 EST
Length:  
45
 mins
Learn more
Empowering the SDLC Process with Tools to Bridge R&D and QualityEmpowering the SDLC Process with Tools to Bridge R&D and Quality
live 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:  
45
 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
Git for IEC 62304: Traceability for software design, unit testing, and requirementsGit for IEC 62304: Traceability for software design, unit testing, and requirements
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
Why building AI/ML-enabled Medical Devices requires CI/CD: A transition pathWhy building AI/ML-enabled Medical Devices requires CI/CD: A transition path
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
Making Jira Fit for 62304: Developing FDA-Compliant SoftwareMaking Jira Fit for 62304: Developing FDA-Compliant Software
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
FDA Cyber Guidance: Implications for SOUP and OTS Risk ManagementFDA Cyber Guidance: Implications for SOUP and OTS Risk Management
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
New FDA OTS Guidance: How to Manage Risk and Testing at ScaleNew FDA OTS Guidance: How to Manage Risk and Testing at Scale
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.
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Postmarket Surveillance of AI Systems: Proactive methods for identifying risk and improving product qualityPostmarket Surveillance of AI Systems: Proactive methods for identifying risk and improving product quality
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
Transitioning to FDA’s New Premarket Submission Guidance: Impact on Quality Systems and Development PracticesTransitioning to FDA’s New Premarket Submission Guidance: Impact on Quality Systems and Development Practices
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).
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The Future of Change Management for Cloud-based AI/ML Medical SoftwareThe Future of Change Management for Cloud-based AI/ML Medical Software
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
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Using a risk-based approach to comply with FDA's 21 CFR Part 11Using a risk-based approach to comply with FDA's 21 CFR Part 11
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
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