Cybersecurity
28 articles
Internet of Medical Things (IoMT): Regulatory and Cybersecurity Guide
Guide to IoMT regulatory compliance for connected medical devices, covering FDA cybersecurity, SBOM expectations, EU MDR obligations, risk classification, and market access.
Wireless & RF Regulatory Compliance for Medical Devices: FCC, RED, and Global Requirements
Guide to wireless and RF compliance for connected medical devices, including FCC authorization, EU RED, coexistence testing, cybersecurity and global market access.
Cloud-Based Medical Devices & SaaS: Regulatory Compliance Guide (FDA, EU MDR 2026)
Guide to FDA and EU MDR regulation of cloud-based medical devices and SaaS health platforms, covering SaMD, SiMD, IEC 62304, cybersecurity, CSA, CRA, and validation.
HIPAA Compliance for Medical Device Companies (2026 Security Rule Update)
Manage HIPAA compliance for connected device companies, including applicability, 2026 Security Rule proposals, encryption, MFA, BAAs, IoMT risks, and FDA cybersecurity overlap.
Mobile Medical Applications: FDA & EU MDR Regulatory Guide (2026)
Classify mobile medical apps under FDA and EU MDR rules, including device software functions, wellness exclusions, CDS updates, Rule 11, cybersecurity, privacy, app stores, and 2026 strategy.
EU Cyber Resilience Act (CRA) + NIS2: Impact on Medical Device Manufacturers in 2026-2027
Explains how the EU CRA and NIS2 affect medical device companies, including MDR/IVDR exemptions, indirect CRA exposure, supply chain duties, and deadlines.
SBOM for Medical Devices: FDA Section 524B, EU CRA, and NTIA Guide
Medical device SBOM guide covering FDA cyber device requirements, NTIA minimum elements, SPDX and CycloneDX formats, VEX integration, tooling, and postmarket management.
Medical Device Cybersecurity: FDA Requirements, SBOM and Compliance Guide
Learn FDA Section 524B cybersecurity expectations for medical devices, including SBOMs, threat modeling, premarket evidence, vulnerability management, and EU MDR alignment.