Fidelity

Regulated Development Resources

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

Brochure
Regulatory
Pathways

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

Checklist
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.

Brochure
SaMD Regulatory Requirements

Learn which regulations and standards are necessary to meet compliance

White Paper
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?

White Paper
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.

Demo

Are you Building a
Software as a Medical Device (SaMD) Application?

What if you could create SaMD products at 10% of today's cost?
Join Ketryx's Startup Waitlist and create your SaMD in weeks, not years.