
FDA SaMD Classification: AI & Machine Learning Guide
Understand FDA SaMD classification for AI/ML devices. Review risk levels (Class I-III), 510(k) pathways, and regulatory guidelines for medical software.

Understand FDA SaMD classification for AI/ML devices. Review risk levels (Class I-III), 510(k) pathways, and regulatory guidelines for medical software.

Understand EU MDR and AI Act compliance for AI medical devices. Explains classification, conformity assessment, and technical documentation requirements.

Learn cybersecurity requirements for AI medical devices. Covers FDA guidance, EU regulations, SBOM mandates, and defenses against adversarial AI attacks.

Analysis of AI medical devices in 2025. Learn about market growth, 950+ FDA-cleared devices, new regulations like the EU AI Act, and key clinical challenges.
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