Jira for IEC 62304: Developing FDA-Compliant Software

Explore how to structure Jira to meet IEC 62304 requirements. This webinar will review each of the major sections from 62304, reveal the gaps in Jira for fulfilling that section, and provide a set of recommendations for fulfilling each section. In addition, we’ll provide practical examples by showcasing a Jira instance configured to meet IEC 62304.

What you’ll learn:

Understand Jira’s critical gaps in meeting IEC 62304 and the challenges posed.

Learn effective strategies for integrating Jira into regulated development workflows, with a focus on customization and configuration to align with IEC 62304 requirements.

Review a live, 62304-compliant Jira instance automatically configured by Ketryx for SaMD development

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