ADO for IEC 62304 and AI: Developing FDA-Compliant Software in Azure DevOps

April 1, 2025, 11:00 am EST • 60 mins

Recorded on April 1, 2025 • 60 mins

Azure DevOps (ADO) is a powerful tool for managing software development, but for medical device manufacturers looking to ensure compliance with IEC 62304—especially when integrating AI—it poses unique challenges. Without the right configuration, teams struggle with manual traceability, fragmented risk management, and automated documentation.

This webinar explores how to adapt ADO for IEC 62304 compliance, automating traceability, risk controls, and documentation and accelerating release cycles. Our experts showcase how to enforce your QMS in ADO, with a live demonstration and interactive Q&A.

What you'll learn

This webinar covers:

  • The limitations of ADO in meeting IEC 62304 compliance and how to automate traceability across requirements, risks, and tests without manual linking
  • Best practices for integrating AI development into a compliant software lifecycle, highlighting integrated risk management and change management
  • A walkthrough of an ADO environment configured for SaMD development and AI governance

Clips from this Webinar

Speakers

Gabriel Pascualy

Head of Product
Ketryx
Formerly Principal Investigator, MITRE

Carlton O'Neal

Product Manager
Ketryx
Formerly