Topic
Digital Health & AI
3 articles
Digital Health & AI
Medical Device Cybersecurity: FDA Requirements, SBOM, Threat Modeling, and Compliance Guide
The complete guide to medical device cybersecurity regulations — FDA Section 524B requirements, SBOM, threat modeling, premarket submissions, post-market vulnerability management, and EU MDR cybersecurity obligations.
81 min read2026-03-25
›Digital Health & AI
Software as a Medical Device (SaMD): The Complete Regulatory Guide
Everything you need to know about SaMD regulation — IMDRF classification, FDA pathways, EU MDR Rule 11, IEC 62304, IEC 82304-1, AI/ML frameworks, PCCP, Digital Health Center of Excellence, international SaMD frameworks (UK, Canada, Japan, Australia), cybersecurity, real product examples, and practical implementation guidance.
62 min read2026-03-22
›Digital Health & AI
IEC 62304 Medical Device Software Lifecycle: The Complete Implementation Guide
How to implement IEC 62304 for medical device software development — safety classification, lifecycle processes, SOUP management, documentation requirements, and practical tips for agile teams.
79 min read2026-03-17
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