Cybersecurity

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.

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.

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.