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White Paper

A Playbook for Transforming Jira to Support IEC 62304 Compliance

To bridge the gap between Jira’s capabilities and IEC 62304 requirements, Ketryx offers integration that extends Jira’s functionality to support compliance. Learn how Ketryx transforms Jira into a powerful tool for IEC 62304-compliant software development.
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Learn how to navigate the challenges of using Jira for regulated medical device software development with this comprehensive guide. This white paper outlines actionable strategies to align Jira with IEC 62304 requirements, enabling efficient development while maintaining compliance. Discover how to integrate risk management, traceability, and automated documentation to streamline workflows and accelerate time-to-market without compromising regulatory standards.

What you'll learn:

  • How to transform Jira into a compliant development tool while maintaining agile workflows.
  • Best practices for achieving end-to-end traceability, risk management, and automated compliance documentation.
  • Strategies to eliminate inefficiencies caused by disconnected tools and manual processes, improving both speed and quality.

Download this essential resource to optimize your Jira implementation for medical device software development, ensuring both innovation and regulatory success.

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White Paper