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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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## More resources

[Checklist\\
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**IEC 62304 Compliance Checklist**\\
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Companies can take a few key steps to simplify their FDA compliance journey and start building medical software. Use this checklist to go through these key steps.\\
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Read more](https://www.ketryx.com/white-papers/iec-62304-compliance-checklist)

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**Modernizing FDA-Grade Software Development with Validated DevOps**\\
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Discover how Validated DevOps can help you develop software faster while staying compliant. \\
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Read more](https://www.ketryx.com/white-papers/validated-devops-white-paper)

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**IDC Spotlight: Connected Life-Cycle Management Streamlines Software Development for Medical Devices**\\
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This Spotlight Paper from leading technology analyst IDC explores how Connected Lifecycle Management (CLM) is transforming software development for regulated industries. \\
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Read more](https://www.ketryx.com/white-papers/idc-clm-spotlight-paper)

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**Discover Why Traceability Doesn't Have to Be So Hard**\\
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Explore why traceability has traditionally been so challenging in medical software development and why cloud and AI only add to the complexity.\\
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Read more](https://www.ketryx.com/white-papers/discover-why-traceability-doesnt-have-to-be-so-hard)