[Skip to main content](https://www.ketryx.com/learn/white-papers#) White Papers # 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. \\ \\ Download](https://www.ketryx.com/white-papers/qms-optimization-workshop-template) [**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. \\ \\ Download](https://www.ketryx.com/white-papers/a-playbook-for-transforming-jira-to-support-iec-62304-compliance) [**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. \\ \\ Download](https://www.ketryx.com/white-papers/idc-clm-spotlight-paper) [**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.\\ \\ Download](https://www.ketryx.com/white-papers/fda-cyber-guidance-and-the-software-supply-chain-a-playbook-for-shifting-left) [**FDA PCCP Compliance Guide** \\ Learn more about the FDA's guidance on PCCPs (Predetermined Change Control Plans) for AI/ML-enabled medical device software. \\ \\ Download](https://www.ketryx.com/white-papers/fda-pccp-compliance-guide) [**Modernizing FDA-Grade Software Development with Validated DevOps** \\ Discover how Validated DevOps can help you develop software faster while staying compliant. \\ \\ Download](https://www.ketryx.com/white-papers/validated-devops-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.\\ \\ Download](https://www.ketryx.com/white-papers/ci-cd-ai-ml-white-paper) [**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](https://www.ketryx.com/white-papers/pccp-template) [**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.\\ \\ Download](https://www.ketryx.com/white-papers/discover-why-traceability-doesnt-have-to-be-so-hard) [**Regulatory Pathways** \\ Learn about the different approval pathways possible, and how to find the one that works best for you.\\ \\ Download](https://www.ketryx.com/white-papers/regulatory-pathways) [**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.\\ \\ Download](https://www.ketryx.com/white-papers/iec-62304-compliance-checklist) [**SaMD Regulatory Requirements** \\ Learn which regulations and standards are necessary to meet compliance for Software as a Medical Device.\\ \\ Download](https://www.ketryx.com/white-papers/samd-regulatory-requirements) [**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](https://www.ketryx.com/white-papers/the-cost-of-quality) [**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](https://www.ketryx.com/white-papers/javascript-static-analysis-tools-for-medical-devices) [**Inside the FDA Regulatory Process** \\ Former FDA software systems safety expert, Paul Jones, shares his insights.\\ \\ Download](https://www.ketryx.com/white-papers/inside-the-fda-regulatory-process) Are You Building Medical Software? ## Get started building software in minutes, not months. [Book a demo](https://www.ketryx.com/schedule-demo) .png) Meet the Ketryx Platform # AI-powered lifecycle management for life science teams The only developer-first connected lifecycle management platform built to use your preferred tooling [Preview Product](https://app.ketryx.com/auth/signup) 6 Specialized AI Agents: In everyday DevTools, like: