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Share your details to download the IEC 62304 Compliance Checklist
Share your details to download the SaMD Regulatory Requirements Brochure
Share your details to download the JavaScript Static Analysis Tools for Medical Devices Whitepaper
Share your details to download the The Cost of Quality White Paper
Regulated Development Resources
FDA software regulations and compliance education designed for developers, builders, and software quality professionals
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.
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Software as a Medical Device (SaMD) Application?
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