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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.
Are You Building Medical Software?
What if you could create regulated applications at 10% of today's cost?
Get started building software in minutes, not months.
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