
FDA Digital Health Guidance: 2026 Requirements Overview
Analysis of FDA digital health guidance covering SaMD, AI, and cybersecurity. Understand 2026 updates, risk categorization, and regulatory compliance pathways.

Analysis of FDA digital health guidance covering SaMD, AI, and cybersecurity. Understand 2026 updates, risk categorization, and regulatory compliance pathways.

A comprehensive guide to the IEC 62304 standard for medical device software, updated for 2026. Covers life cycle processes, safety classification, Edition 2.0 draft changes, FDA QMSR alignment, IEC 81001-5-1 cybersecurity, and regulatory compliance across FDA and EU MDR.
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