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SaMD Development Playbook

Software as a medical device is regulated just like traditional devices, and ISO 13485, ISO 14971, IEC 62304, and QMSR all apply. This playbook brings together the guides, webinars, podcasts, and tools that help teams build
audit-ready software without stalling releases.

Everything you need to build compliant, effective SaMD, all in one place.

✓   Guidance on IEC 62304, ISO 13485, and FDA requirements
✓   Webinars from some of the industry's foremost experts

✓   Deep insights and actionable tips on developing audit-ready SaMD

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