FDA mandates make medical cybersecurity a legal prerequisite for device launches. We review Software Bill of Materials (SBOM) audits, threat modeling, and healthcare security.
Connected medical devices improve patient care, but expose hospital networks to malware. FDA guidelines require manufacturers to prove their devices resist tampering.
A structured compliance plan must catalog software dependencies, document secure update procedures, and analyze threat models before submitting devices for approval.
Key Pillars of Assessment
SBOM Inventories
Cataloging all open-source libraries and APIs in the device software.
Cryptographic Signatures
Signing system updates to prevent malicious software installation.
Device Segregation
Designing hospital networks to isolate medical devices from business computers.
Vulnerability Disclosures
Establishing pathways for reporting and patching post-launch security issues.
Legacy Device Management in Hospital Environments
Hospitals run hundreds of legacy medical devices with operating systems that no longer receive security patches. Securing these assets requires network micro-segmentation, firewall filters, and continuous traffic monitoring.
We help manufacturers and healthcare networks run threat simulations, identify exposure risks, and build secure network architectures that isolate critical systems.
Legacy Device Management in Hospital Environments
- Reviewing device codebases for hardcoded credentials.
- Implementing network security templates tailored for hospital infrastructure.
- Drafting FDA-compliant security documentation for device applications.
Deliver Secure Patient Care Systems
Healthcare compliance protects patient safety and database records. Partner with our medical security team to audit your device codebases and meet FDA requirements.