[Skip to main content](https://www.ketryx.com/learn/webinars#)

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On-Demand Webinar\\
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**How Meta Preserves a Best-in-Class Engineering Culture in a Regulated Environment**\\
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Date:  \\
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December 18, 2025\\
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Recorded:  \\
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December 18, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/how-meta-preserves-a-best-in-class-engineering-culture-in-a-regulated-environment)

[On-Demand Webinar\\
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**Paving the Way for Continuous Innovation: Navigating FDA PCCP Authorization for AI-Driven Medical Devices**\\
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Date:  \\
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June 26, 2025\\
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Recorded:  \\
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June 26, 2025\\
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Time:  \\
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1:00 pm\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/paving-the-way-for-continuous-innovation-navigating-fda-pccp-authorization-for-ai-driven-medical-devices)

[On-Demand Webinar\\
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**How to Use AI Agents in Safety-Critical Industries**\\
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Date:  \\
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May 14, 2025\\
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Recorded:  \\
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May 14, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/how-to-use-ai-agents-in-safety-critical-industries)

[On-Demand Webinar\\
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**Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements**\\
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Date:  \\
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October 31, 2024\\
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Recorded:  \\
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October 31, 2024\\
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Time:  \\
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11:00 am\\
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Length:  \\
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60\\
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mins\\
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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. \\
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Learn more](https://www.ketryx.com/learn/webinars/register/git-for-iec-62304-2024-10-31)

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[Validation](https://www.ketryx.com/learn/webinars#)

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Live Webinar\\
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**How to Validate AI-Enabled, Non-Product Software, Fast**\\
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Date:  \\
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June 4, 2026\\
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Recorded:  \\
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June 4, 2026\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/how-to-validate-ai-enabled-non-product-software)

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Live Webinar\\
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**Streamlining Multi-Region Submissions: MDR, FDA, and EU AI Act**\\
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Date:  \\
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April 27, 2026\\
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Recorded:  \\
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April 27, 2026\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/streamlining-multi-region-submissions-with-raps)

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Live Webinar\\
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**Why Resubmit When You Can Ship? How to Accelerate Innovation with PCCPs and CI/CD**\\
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Date:  \\
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April 2, 2026\\
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Recorded:  \\
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April 2, 2026\\
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Time:  \\
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12:00 pm\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/why-resubmit-when-you-can-ship-how-to-accelerate-innovation-with-pccps-and-ci-cd)

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Live Webinar\\
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**How Flo Is Building Regulatory Readiness, Fast**\\
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Date:  \\
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March 17, 2026\\
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Recorded:  \\
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March 17, 2026\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/rerun-how-flo-is-building-regulatory-readiness-fast)

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On-Demand Webinar\\
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**Product Spotlight Webinar - Google Drive as a Governed Part of Your eQMS**\\
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Date:  \\
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February 12, 2026\\
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Recorded:  \\
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February 12, 2026\\
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Time:  \\
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12:00 pm\\
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EST\\
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Length:  \\
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45\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/product-spotlight-webinar---google-drive-as-a-governed-part-of-your-eqms)

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On-Demand Webinar\\
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**Breaking the Change Impact Assessment Bottleneck with AI**\\
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Date:  \\
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February 18, 2026\\
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Recorded:  \\
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February 18, 2026\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/breaking-the-change-impact-assessment-bottleneck)

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On-Demand Webinar\\
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**Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements**\\
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Date:  \\
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January 29, 2026\\
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Recorded:  \\
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January 29, 2026\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/git-for-iec-62304-jan-25)

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On-Demand Webinar\\
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**Jira for IEC 62304: Developing FDA-Compliant Software**\\
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Date:  \\
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January 6, 2026\\
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Recorded:  \\
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January 6, 2026\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Agile moves fast, but Jira alone wasn’t built to meet the regulatory rigor required for medical device software. Under IEC 62304, that gap shows up as broken traceability, last-minute scramble to complete documentation, and endless manual copy-pasting. This webinar breaks down what regulators expect from teams operating under IEC 62304, the common gaps that appear in real-world Jira implementations, and how AI can reduce manual compliance work without weakening oversight.\\
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Learn more](https://www.ketryx.com/learn/webinars/register/jira-for-iec-62304-jan-25)

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On-Demand Webinar\\
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**How Flo Is Building Regulatory Readiness for Its AI-Enabled Digital Health App, Fast**\\
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Date:  \\
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November 11, 2025\\
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Recorded:  \\
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November 11, 2025\\
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Time:  \\
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12:00 pm\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/how-flo-is-building-regulatory-readiness-for-its-ai-enabled-digital-health-app-fast)

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On-Demand Webinar\\
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**Streamlining Multi-Region Submissions: Orchestrating MDR, FDA, and EU AI Act Documentation for AI-Enabled Devices**\\
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Date:  \\
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November 20, 2025\\
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Recorded:  \\
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November 20, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/streamlining-multi-region-submissions)

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On-Demand Webinar\\
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**How to Use Agentic AI to Systematically Prevent Deviations**\\
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Date:  \\
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October 14, 2025\\
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Recorded:  \\
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October 14, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/how-to-use-agentic-ai-to-systematically-prevent-deviations)

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On-Demand Webinar\\
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**Solving the Agile Dilemma: Speed and Safety for AI/ML-Enabled Medical Devices**\\
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Date:  \\
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September 16, 2025\\
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Recorded:  \\
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September 16, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/the-agile-advantage-speed-and-safety-for-ai-ml-enabled-medical-devices)

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Live Webinar\\
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**Validating AI & LLMs in GxP Use Cases**\\
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Date:  \\
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August 14, 2025\\
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Recorded:  \\
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August 14, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/validating-ai-llms-in-gxp-use-cases)

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On-Demand Webinar\\
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**Paving the Way for Continuous Innovation: Navigating FDA PCCP Authorization for AI-Driven Medical Devices**\\
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Date:  \\
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June 26, 2025\\
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Recorded:  \\
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June 26, 2025\\
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Time:  \\
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1:00 pm\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/paving-the-way-for-continuous-innovation-navigating-fda-pccp-authorization-for-ai-driven-medical-devices)

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On-Demand Webinar\\
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**How to Use AI Agents in Safety-Critical Industries**\\
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Date:  \\
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May 14, 2025\\
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Recorded:  \\
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May 14, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/how-to-use-ai-agents-in-safety-critical-industries)

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On-Demand Webinar\\
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**Simplifying 62304 and AI Compliance with Jira & Polarion**\\
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Date:  \\
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June 4, 2025\\
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Recorded:  \\
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June 4, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/simplifying-62304-and-ai-compliance-with-jira-polarion)

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On-Demand Webinar\\
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**Validating AI & LLMs in GxP Use Cases for Pharma**\\
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Date:  \\
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April 22, 2025\\
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Recorded:  \\
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April 22, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/validating-ai-llms-in-gxp-use-cases-for-pharma)

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On-Demand Webinar\\
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**Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements**\\
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Date:  \\
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May 6, 2025\\
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Recorded:  \\
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May 6, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/git-for-iec-62304-traceability-for-software-design-unit-testing-requirements-2025-05-06)

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On-Demand Webinar\\
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**ADO for IEC 62304 and AI: Developing FDA-Compliant Software in Azure DevOps**\\
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Date:  \\
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April 1, 2025\\
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Recorded:  \\
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April 1, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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Learn more](https://www.ketryx.com/learn/webinars/register/ado-for-iec-62304-and-ai-developing-fda-compliant-software-in-azure-devops)

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On-Demand Webinar\\
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**Building an Audit-Ready Secure SDLC: Traceability Across Cybersecurity Risks & Vulnerabilities**\\
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Date:  \\
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March 18, 2025\\
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Recorded:  \\
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March 18, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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. ‍\\
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Learn more](https://www.ketryx.com/learn/webinars/register/building-an-audit-ready-secure-sdlc)

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On-Demand Webinar\\
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**Understanding the FDA's New Draft Guidance on AI-Enabled Devices: What MedTech Companies Need to Know**\\
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Date:  \\
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February 26, 2025\\
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Recorded:  \\
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February 26, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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. \\
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Learn more](https://www.ketryx.com/learn/webinars/register/understanding-the-fdas-new-draft-guidance-on-ai-enabled-devices-what-medtech-companies-need-to-know)

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On-Demand Webinar\\
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**Navigating the FDA’s Total Product Lifecycle Framework for Generative AI Devices**\\
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Date:  \\
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January 15, 2025\\
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Recorded:  \\
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January 15, 2025\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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.\\
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Learn more](https://www.ketryx.com/learn/webinars/register/navigating-the-fdas-total-product-lifecycle-framework-for-generative-ai-devices)

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On-Demand Webinar\\
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**FDA-Grade AI: Total Product Lifecycle Control with a PCCP**\\
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Date:  \\
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December 17, 2024\\
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Recorded:  \\
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December 17, 2024\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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.\\
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Learn more](https://www.ketryx.com/learn/webinars/register/fda-grade-ai-total-product-lifecycle-control-with-a-pccp)

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On-Demand Webinar\\
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**SBOM and Beyond: FDA-Compliant Cybersecurity Vulnerability Management**\\
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Date:  \\
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November 19, 2024\\
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Recorded:  \\
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November 19, 2024\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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. \\
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Learn more](https://www.ketryx.com/learn/webinars/register/sbom-and-beyond-fda-compliant-cybersecurity-vulnerability-management-2)

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On-Demand Webinar\\
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**Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements**\\
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Date:  \\
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October 31, 2024\\
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Recorded:  \\
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October 31, 2024\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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. \\
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Learn more](https://www.ketryx.com/learn/webinars/register/git-for-iec-62304-2024-10-31)

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On-Demand Webinar\\
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**Jira for IEC 62304: Developing FDA-Compliant Software**\\
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Date:  \\
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October 3, 2024\\
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Recorded:  \\
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October 3, 2024\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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.\\
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Learn more](https://www.ketryx.com/learn/webinars/register/jira-for-iec-62304-developing-fda-compliant-software)

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On-Demand Webinar\\
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**Transitioning from Monolithic to Microservices: How to Adopt a Systems of Systems Approach for Your SDLC**\\
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Date:  \\
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September 5, 2024\\
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Recorded:  \\
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September 5, 2024\\
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Time:  \\
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11:00 am\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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.\\
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Learn more](https://www.ketryx.com/learn/webinars/register/transitioning-from-monolithic-to-microservices-how-to-adopt-a-systems-of-systems-approach-for-your-sdlc)

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On-Demand Webinar\\
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**Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices**\\
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Date:  \\
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July 16, 2024\\
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Recorded:  \\
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July 16, 2024\\
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Time:  \\
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1:00 pm\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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.\\
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Learn more](https://www.ketryx.com/learn/webinars/register/implementing-a-pccp-ci-cd-for-ai-ml-enabled-medical-devices)

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On-Demand Webinar\\
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**62304-Compliant Traceability for Automated Testing**\\
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Date:  \\
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June 18, 2024\\
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Recorded:  \\
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June 18, 2024\\
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Time:  \\
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1:00 pm\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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.\\
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Learn more](https://www.ketryx.com/learn/webinars/register/62304-compliant-traceability-for-automated-testing)

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On-Demand Webinar\\
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**Empowering the SDLC Process with Tools to Bridge R&D and Quality**\\
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Date:  \\
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May 15, 2024\\
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Recorded:  \\
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May 15, 2024\\
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Time:  \\
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12:00 pm\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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.\\
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Learn more](https://www.ketryx.com/learn/webinars/register/empowering-sdlc-process-tools-bridge-rd-quality)

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On-Demand Webinar\\
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**Git for IEC 62304: Traceability for software design, unit testing, and requirements**\\
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Date:  \\
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April 18, 2024\\
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Recorded:  \\
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April 18, 2024\\
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Time:  \\
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1:00 pm\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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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Learn more](https://www.ketryx.com/learn/webinars/register/git-for-iec-62304-traceability-for-software-design-unit-testing-and-requirements)

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On-Demand Webinar\\
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**Why building AI/ML-enabled Medical Devices requires CI/CD: A transition path**\\
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Date:  \\
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March 20, 2024\\
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Recorded:  \\
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March 20, 2024\\
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Time:  \\
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4:00 pm\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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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Learn more](https://www.ketryx.com/learn/webinars/register/why-building-ai-ml-enabled-medical-devices-requires-ci-cd-a-transition-path)

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On-Demand Webinar\\
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**FDA Cyber Guidance: Implications for SOUP and OTS Risk Management**\\
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Date:  \\
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February 14, 2024\\
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Recorded:  \\
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February 14, 2024\\
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Time:  \\
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4:00 pm\\
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EST\\
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Length:  \\
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60\\
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mins\\
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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."\\
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Learn more](https://www.ketryx.com/learn/webinars/register/fda-cyber-guidance-implications-for-soup-and-ots-risk-management)

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On-Demand Webinar\\
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**New FDA OTS Guidance: How to Manage Risk and Testing at Scale**\\
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Date:  \\
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January 17, 2024\\
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Recorded:  \\
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January 17, 2024\\
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Time:  \\
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4:00 pm\\
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EST\\
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Length:  \\
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30\\
\\
mins\\
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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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Learn more](https://www.ketryx.com/learn/webinars/register/soup-ots-manage-risk-testing-scale)

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On-Demand Webinar\\
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**Postmarket Surveillance of AI Systems: Proactive methods for identifying risk and improving product quality**\\
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Date:  \\
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December 13, 2023\\
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Recorded:  \\
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December 13, 2023\\
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Time:  \\
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4:00 pm\\
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EST\\
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Length:  \\
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30\\
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mins\\
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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](https://www.ketryx.com/learn/webinars/register/postmarket-surveillance-of-ai-systems-proactive-methods-for-identifying-risk-and-improving-product-quality)

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On-Demand Webinar\\
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**Transitioning to FDA’s New Premarket Submission Guidance: Impact on Quality Systems and Development Practices**\\
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Date:  \\
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Recorded:  \\
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Time:  \\
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EST\\
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Length:  \\
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30\\
\\
mins\\
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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](https://www.ketryx.com/learn/webinars/register/transitioning-to-fdas-new-premarket-submission-guidance)

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On-Demand Webinar\\
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**The Future of Change Management for Cloud-based AI/ML Medical Software**\\
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Date:  \\
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Recorded:  \\
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Time:  \\
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EST\\
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Length:  \\
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30\\
\\
mins\\
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The Future of Change Management for Cloud-based AI/ML Medical Software - Best practices for cloud change management - Ketryx\\
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Learn more](https://www.ketryx.com/learn/webinars/register/the-future-of-change-management-for-cloud-based-ai-ml-medical-software)

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On-Demand Webinar\\
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**Using a risk-based approach to comply with FDA's 21 CFR Part 11**\\
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Date:  \\
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October 11, 2023\\
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Recorded:  \\
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October 11, 2023\\
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Time:  \\
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4:00 pm\\
\\
EST\\
\\
Length:  \\
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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](https://www.ketryx.com/learn/webinars/register/using-a-risk-based-approach-to-comply-with-fda)

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