# Regulated Development Resources

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

### [QMS Optimization Workshop Template](/content/white-papers/qms-optimization-workshop-template/index.html)
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.

### [A Playbook for Transforming Jira to Support IEC 62304 Compliance](/content/white-papers/a-playbook-for-transforming-jira-to-support-iec-62304-compliance/index.html)
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.

### [IDC Spotlight: Connected Life-Cycle Management Streamlines Software Development for Medical Devices](/content/white-papers/idc-clm-spotlight-paper/index.html)
This Spotlight Paper from leading technology analyst IDC explores how Connected Lifecycle Management (CLM) is transforming software development for regulated industries.

### [FDA Cyber Guidance and the Software Supply Chain: A Playbook for Shifting Left](/content/white-papers/fda-cyber-guidance-and-the-software-supply-chain-a-playbook-for-shifting-left/index.html)
Discover how to navigate the complex landscape of cybersecurity for medical devices with this comprehensive guide.

### [FDA PCCP Compliance Guide](/content/white-papers/fda-pccp-compliance-guide/index.html)
Learn more about the FDA's guidance on PCCPs (Predetermined Change Control Plans) for AI/ML-enabled medical device software.

### [Modernizing FDA-Grade Software Development with Validated DevOps](/content/white-papers/validated-devops-white-paper/index.html)
Discover how Validated DevOps can help you develop software faster while staying compliant.

### [A Guide To Implementing CI/CD in Your AI/ML SaMD Projects](/content/white-papers/ci-cd-ai-ml-white-paper/index.html)
Learn why CI/CD is crucial for AI/ML SaMD development and how you can transition your organization to CI/CD.

### [FDA Predetermined Change Control Plan (PCCP) Template](/content/white-papers/pccp-template/index.html)
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.

### [Discover Why Traceability Doesn't Have to Be So Hard](/content/white-papers/discover-why-traceability-doesnt-have-to-be-so-hard/index.html)
Explore why traceability has traditionally been so challenging in medical software development and why cloud and AI only add to the complexity.

### [Regulatory Pathways](/content/white-papers/regulatory-pathways/index.html)
Learn about the different approval pathways possible, and how to find the one that works best for you.

### [IEC 62304 Compliance Checklist](/content/white-papers/iec-62304-compliance-checklist/index.html)
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.

### [SaMD Regulatory Requirements](/content/white-papers/samd-regulatory-requirements/index.html)
Learn which regulations and standards are necessary to meet compliance for Software as a Medical Device.

### [The Cost of Quality](/content/white-papers/the-cost-of-quality/index.html)
What is quality and why can it make creating products more expensive? What is the cost of creating high quality products?

### [JavaScript Static Analysis Tools for Medical Devices](/content/white-papers/javascript-static-analysis-tools-for-medical-devices/index.html)
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.

### [Inside the FDA Regulatory Process](/content/white-papers/inside-the-fda-regulatory-process/index.html)
Former FDA software systems safety expert, Paul Jones, shares his insights.

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