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White Paper

# A Guide To Implementing CI/CD in Your AI/ML SaMD Projects

Learn why CI/CD is crucial for AI/ML SaMD development and how you can transition your organization to CI/CD.

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[](https://www.ketryx.com/white-papers/ci-cd-ai-ml-white-paper#) [](https://www.ketryx.com/white-papers/ci-cd-ai-ml-white-paper#)

The number of AI-powered medical devices is rapidly increasing, with 950 AI/ML-enabled devices already authorized by the FDA. However, the journey to successfully developing and managing these complex systems remains challenging for many manufacturers. Continuous Integration/Continuous Deployment (CI/CD) is now essential for enabling AI/ML in medical software. Medical software teams can align this practice with FDA guidance to ensure product safety while accelerating development timelines.

Download the white paper to explore:

1. **Why CI/CD is crucial for AI/ML SaMD development**: Discover how CI/CD supports incremental changes, tighter feedback loops, and faster delivery of safe, reliable medical software.
2. **Challenges and Solutions**: Learn about the unique challenges of implementing CI/CD in regulated environments and the steps you can take to overcome them.
3. **Best Practices for Transitioning to CI/CD**: Get actionable insights on designing an architecture built for change, automating documentation, and maintaining end-to-end traceability.

Implementing CI/CD is now a necessity for medical device software development. Our white paper provides you with the knowledge and tools needed to make this transition seamlessly while maintaining compliance and improving product quality.

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## More resources

[Template\\
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**FDA Predetermined Change Control Plan (PCCP) Template**\\
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This template is designed to assist organizations in developing a comprehensive plan to manage and assess modifications to Machine Learning Device Software Functions (ML-DSFs) in medical devices.\\
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Read more](https://www.ketryx.com/white-papers/pccp-template)

[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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**FDA Cyber Guidance and the Software Supply Chain: A Playbook for Shifting Left**\\
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Discover how to navigate the complex landscape of cybersecurity for medical devices with this comprehensive guide.\\
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Read more](https://www.ketryx.com/white-papers/fda-cyber-guidance-and-the-software-supply-chain-a-playbook-for-shifting-left)

[White Paper\\
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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)