Medical Software Development Resources | SaMD Resources for Devs & Executives - Ketryx

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.

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.

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.

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.

FDA PCCP Compliance Guide

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

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

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

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

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

Regulatory Pathways

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

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.

SaMD Regulatory Requirements

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

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?

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.

Inside the FDA Regulatory Process

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