Discover webinars

Join us for an in-depth exploration of techniques to identify cybersecurity vulnerabilities within your software and generate an FDA-compliant SBOM (Software Bill of Materials) so you can better mitigate threats, ensure compliance, and enhance patient safety.

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.

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.

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.

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.

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.

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."

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.

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.

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).

The Future of Change Management for Cloud-based AI/ML Medical Software - Best practices for cloud change management - Ketryx

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.