Threat modeling for medical devices
Our team has performed dozens of threat models and contributed to the MDIC playbook referenced by regulatory documentation. A threat model is the foundation of device cybersecurity and your regulatory submission. It identifies what needs to be secured, why, and to what level. Done well, it ensures your cybersecurity program covers the right attack surfaces and your documentation tells a coherent story to reviewers.
How you get value from our threat modeling help
Device architecture review
We map your device's components, interfaces, data flows, and communication pathways to identify the full exposure surface. This includes the device itself, companion applications, cloud infrastructure, wireless protocols, and any third-party components or libraries.
Threat identification
We identify potential threats aligned to your device's clinical context. This goes beyond generic threat libraries: we evaluate threats specific to your device category and its intended use, drawing on real-world examples.
Risk characterization
Threats are characterized by potential impact on patient safety and clinical effectiveness. This characterization maps directly to your hazard analysis and supports the risk management documentation regulators expect.
Testing scope definition
The threat model directly defines what penetration testing should cover and why. This ensures testing coverage is focused on high-relevance attack surfaces and produces the traceability that reviewers look for between threat identification and testing evidence.
Standards alignment
Our threat modeling methodology aligns with AAMI TIR57, ISO 14971, IEC 81001-5-1, and FDA premarket guidance. The output integrates with your broader risk management and quality system documentation.
Standalone or integrated with full penetration testing
Threat modeling can be engaged as a standalone service, which can reduce timeline and costs for manufacturers early in development who want to build security in from the design phase, or as the first step of a full penetration testing engagement. Many clients start here and move into testing once the scope is defined. If you've already completed a threat model with another firm or internally, we can review it before testing begins.