Regulated Development Resources

FDA software regulations and compliance education designed for developers, builders, and software quality professionals

[**QMS Optimization Workshop Template**
This practical workshop template is designed to guide regulated teams in regular QMS reviews to identify process debt and apply a modern, risk-based, AI-assisted approach to quality processes.

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[**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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[**IDC Spotlight: Connected Life-Cycle Management Streamlines Software Development for Medical Devices**
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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[**FDA Cyber Guidance and the Software Supply Chain: A Playbook for Shifting Left**
Discover how to navigate the complex landscape of cybersecurity for medical devices with this comprehensive guide.

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[**FDA PCCP Compliance Guide**
Learn more about the FDA's guidance on PCCPs (Predetermined Change Control Plans) for AI/ML-enabled medical device software.

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[**Modernizing FDA-Grade Software Development with Validated DevOps**
Discover how Validated DevOps can help you develop software faster while staying compliant.

Download](/content/white-papers/validated-devops-white-paper/index.html)

[**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.

Download](/content/white-papers/ci-cd-ai-ml-white-paper/index.html)

[**FDA Predetermined Change Control Plan (PCCP) Template**
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.

Download](/content/white-papers/pccp-template/index.html)

[**Discover Why Traceability Doesn't Have to Be So Hard**
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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[**Regulatory Pathways**
Learn about the different approval pathways possible, and how to find the one that works best for you.

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[**IEC 62304 Compliance Checklist**
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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[**SaMD Regulatory Requirements**
Learn which regulations and standards are necessary to meet compliance for Software as a Medical Device.

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[**The Cost of Quality**
What is quality and why can it make creating products more expensive? What is the cost of creating high quality products?

Download](/content/white-papers/the-cost-of-quality/index.html)

[**JavaScript Static Analysis Tools for Medical Devices**
The focus of this paper is on software applications written in JavaScript that meet the Food and Drug Administration’s (FDA) regulatory definition of a medical device.

Download](/content/white-papers/javascript-static-analysis-tools-for-medical-devices/index.html)

[**Inside the FDA Regulatory Process**
Former FDA software systems safety expert, Paul Jones, shares his insights.

Download](/content/white-papers/inside-the-fda-regulatory-process/index.html)

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