Regulated Development Resources

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

EU Cyber Resilience Act Compliance Guide
Learn more about the EU Cyber Resilience Act (CRA) and what manufacturers of products with digital elements must do to comply.
Download

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

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

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

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

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

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

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

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

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

Regulatory Pathways
Learn about the different approval pathways possible, and how to find the one that works best for you.
Download

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

SaMD Regulatory Requirements
Learn which regulations and standards are necessary to meet compliance for Software as a Medical Device.
Download

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

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

Ketryx Quality Practices: How Ketryx Builds, Validates, and Governs Its Own Platform
How Ketryx builds and maintains the platform under a certified quality system aligned with ISO 13485, IEC 62304, and ISO 14971 — so your supplier qualification evidence is already audit-ready.
Download

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