White papers

Regulated Development Resources

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

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

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.

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