Digital Health & AI

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.

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.

How to implement IEC 62304 for medical device software development — safety classification, lifecycle processes, SOUP management, documentation requirements, and practical tips for agile teams.