Meeting FDA Premarket Cybersecurity Guidance with Hardware Roots of Trust

Engineering medical device security architectures compliant with FDA Section 524B and EU Medical Device Regulation (MDR).

The FDA's Refusal-to-Accept Cybersecurity Policy

Under Section 524B of the FD&C Act, the FDA can reject medical device submissions that lack robust cybersecurity architectures. MedicalHSM provides medical equipment manufacturers with an off-the-shelf certified hardware root of trust that fulfills all FDA requirements for device integrity, secure updates, and vulnerability management.

Immutable Device Identity and Manufacturing Provenance

During cleanroom fabrication, MedicalHSM receives unique factory-fused X.509 private keys anchored in physical unclonable functions (PUFs), allowing hospital networks to verify device authenticity before granting clinical network access.

Software Bill of Materials (SBOM): Cryptographically signing device firmware components and dependency trees.
Vulnerability Disclosure Readiness: Enforcing secure over-the-air firmware updates with atomic rollback.
Post-Market Surveillance: Generating cryptographically signed audit logs capturing clinical device state transitions.
Zero-Trust Device Identity: Provisioning immutable IEEE 802.1AR device certificates during manufacturing.

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