Medical Device Cybersecurity

The Problem We Solve

Since October 2023, the FDA requires cybersecurity plans, threat models, Software Bill of Materials, and post-market monitoring commitments for all connected device submissions. Non-compliant submissions are refused at the gate. This is not a future requirement — it is already causing delays for companies that have not prepared. We integrate cybersecurity into your device architecture and your regulatory submission from the start.

What We Do

Four cybersecurity disciplines — embedded in device engineering and regulatory, not outsourced to an IT firm.

🔍 Threat Modelling & Risk Assessment

STRIDE-based threat identification across all device interfaces
Attack surface analysis: BLE, Wi-Fi, cellular, USB, cloud APIs
Threat risk rating and mitigation priority mapping
Cybersecurity risk integration with ISO 14971 device risk file
Security architecture review and hardening recommendations

📄 SBOM & Premarket Submission Support

Software Bill of Materials (SBOM) generation and management
Third-party component and library vulnerability tracking
Cybersecurity documentation package for 510(k), PMA, and De Novo
FDA 2023 cybersecurity guidance alignment and compliance checklist
EU MDR and MDCG cybersecurity guidance compliance

🛡️ Penetration Testing & Security Validation

Firmware and embedded software security testing
Network communication and protocol analysis: MQTT, TLS, HL7
Authentication, authorisation, and access control verification
Cryptographic implementation review
Post-fix validation and regression security testing

🔄 Post-Market Cybersecurity Management

CVE monitoring for all device software components
Patch planning and coordinated deployment
Coordinated vulnerability disclosure process setup
Security incident response plan development
Annual cybersecurity review and SBOM refresh

Who This Is For

We work with device companies at every stage — from new submissions to post-market monitoring.

Device companies with connected or wireless-enabled products preparing a new premarket submission

Companies whose FDA submissions have received cybersecurity-related Refuse-to-Accept decisions

Device makers with cleared devices requiring post-market cybersecurity monitoring

Startups building SaMD or cloud-connected monitoring devices from the ground up

Why 369 Innovations

Medical device cybersecurity is not an IT project. It requires understanding of device architecture, regulatory expectations, and clinical risk — simultaneously. Our cybersecurity capability is embedded in the same team that builds and validates your device, so security is never a separate workstream.

Key Differentiator: Device cybersecurity integrated into engineering and regulatory — not outsourced to an IT firm.

Secure by Design. Submission-Ready. Patient-Safe.