Cybersecurity

Learn how HL7 FHIR, IEEE 11073, and DICOM support medical device interoperability, including CMS mandates, FDA expectations, and implementation guidance.

Implement Privacy by Design in connected medical devices, with GDPR, HIPAA, data minimization, consent, anonymization, and 2026 privacy expectations.

Learn how medical device companies can implement ISO 27001, align ISMS controls with ISO 13485 and FDA cybersecurity expectations, and plan certification.

Practical GDPR guide for device and IVD manufacturers, covering health data, DPIAs, DPO duties, lawful bases, transfers, EU MDR, IVDR, and AI Act overlap.

Guide to IoMT regulatory compliance for connected medical devices, covering FDA cybersecurity, SBOM expectations, EU MDR obligations, risk classification, and market access.

Guide to wireless and RF compliance for connected medical devices, including FCC authorization, EU RED, coexistence testing, cybersecurity and global market access.

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.

Manage HIPAA compliance for connected device companies, including applicability, 2026 Security Rule proposals, encryption, MFA, BAAs, IoMT risks, and FDA cybersecurity overlap.

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.

Explains how the EU CRA and NIS2 affect medical device companies, including MDR/IVDR exemptions, indirect CRA exposure, supply chain duties, and deadlines.

Medical device SBOM guide covering FDA cyber device requirements, NTIA minimum elements, SPDX and CycloneDX formats, VEX integration, tooling, and postmarket management.

Learn FDA Section 524B cybersecurity expectations for medical devices, including SBOMs, threat modeling, premarket evidence, vulnerability management, and EU MDR alignment.