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As medical devices become more complex—incorporating AI and increased connectivity—ensuring compliance with FDA and EU MDR requirements is more challenging than ever. Teams responsible for making sure products are safe and effective must manage intricate software supply chains, document SBOMs, and mitigate cybersecurity risks, all while maintaining end-to-end traceability. Without the right processes, compliance gaps can delay product releases and jeopardize patient safety. ‍

Explore key insights from the FDA's AI draft guidance, including data management, model validation, and labeling. Learn strategies to align IEC 62304 QMS and leverage the Predetermined Change Control Plan for iterative AI model improvement.

Discover evidence needs for Generative AI devices, postmarket monitoring strategies for evolving models, and best practices for dataset management to ensure traceability and quality throughout the product lifecycle.

Uncover how AI is transforming medical devices, explore how PCCPs streamline compliance and innovation, and learn to apply agile methodologies in regulated environments while overcoming key challenges.

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.

Explore the critical gaps in Jira’s ability to meet IEC 62304 standards and the challenges it presents for regulated development. Discover effective strategies for integrating and customizing Jira to align with IEC 62304 requirements. Plus, get a live walkthrough of a 62304-compliant Jira instance, automatically configured by Ketryx for seamless SaMD development.

Learn to design adaptable architectures, integrate AI/ML subsystems, and enhance regulatory strategies with modularity and flexibility. Discover tools for version control and traceability in complex microservices environments.

Learn practical strategies for designing and validating PCCPs, post-market ML software release processes, and implementing CI/CD to accelerate AI/ML-enabled SaMD development and compliance.

Learn to trace automated test results from Git to Jira, generate compliant test cases, establish traceability, and integrate testing tools with CI/CD pipelines. Streamline workflows with Jira-GitHub integration.

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.

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.