If your software is designed to affect a patient’s diagnosis, treatment, or ongoing care, it could be classified as a regulated medical device under frameworks like the UK MHRA, EU MDR, or US FDA. But understanding what qualifies—and what’s expected—can be complex.

This free downloadable eBook (PDF) offers a practical roadmap to SaMD compliance without the jargon. It’s tailored for digital health founders, developers, and product teams who need to move fast — without falling foul of regulation.

What you’ll learn

• What qualifies as SaMD – Understand how software is classified under UK, EU, and US frameworks—with real-world examples.

• What regulators expect – Explore risk classification, essential documentation, and cybersecurity requirements for digital health tools.

• Key standards demystified – Break down IEC 62304, ISO 14971, and ISO 13485— without the heavy jargon.

• Early compliance strategies – Learn how to approach quality systems, risk documentation, and regulatory planning.

• A practical starting point – Whether you’re working with a regulatory consultant or going it alone, you’ll gain clarity on next steps.

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Why download it?
This is not just another regulatory checklist. It’s a strategic, plain-language guide to building compliant software faster.

Perfect for:

• Digital health startups and SaMD innovators

• Developers responsible for IEC 62304 documentation

• Product leads preparing for CE, UKCA, or FDA pathways

• Founders seeking funding or partnerships and needing compliance credibility.

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You’ll also discover how Coauthor can automate documentation, link risk controls to testing, and help you stay audit-ready — without the burden of traditional eQMS tools.

Download your free copy now
Enter your email below to access A Beginner’s Guide to SaMD Compliance and start your compliance journey with confidence.