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.

This Spotlight Paper from leading technology analyst IDC explores how Connected Lifecycle Management (CLM) is transforming software development for regulated industries.

Discover how to navigate the complex landscape of cybersecurity for medical devices with this comprehensive guide.

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

Discover how Validated DevOps can help you develop software faster while staying compliant.

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

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.

Explore why traceability has traditionally been so challenging in medical software development and why cloud and AI only add to the complexity.

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

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.

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

What is quality and why can it make creating products more expensive? What is the cost of creating high quality products?

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.

Former FDA software systems safety expert, Paul Jones, shares his insights.