Topic
Cybersecurity
23 articles
EU MDR / IVDR
EU Cyber Resilience Act (CRA) + NIS2: Impact on Medical Device Manufacturers in 2026-2027
Complete guide to how the EU Cyber Resilience Act (CRA) and NIS2 Directive affect medical device manufacturers — including the MDR/IVDR exemption, indirect CRA impact scenarios, NIS2 supply chain obligations, MDCG cybersecurity guidance, timelines, penalties, and compliance strategies.
14 min read2026-04-17
›Cybersecurity
SBOM for Medical Devices: Complete Guide to FDA Section 524B, EU CRA & NTIA Compliance (2026)
Everything medical device manufacturers need to know about Software Bill of Materials — FDA cyber device requirements, NTIA minimum elements, SPDX vs CycloneDX formats, VEX integration, tools, and post-market management strategies.
16 min read2026-04-17
›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
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