Medical Device Threat Modeling
Secure your product. Meet regulatory expectations. Protect patients.
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Why Threat Modeling Matters in MedTech
Medical devices are increasingly connected, and increasingly targeted. A compromised system doesn’t just expose data; it can disrupt therapy, diagnostics, or clinical workflows.
Threat modeling helps you:
- Identify attack paths early in design
- Anticipate unsafe states or functional failures
- Support FDA, IEC 62304 and ISO 14971 requirements
Where in the Lifecycle?
We apply threat modeling across the product lifecycle:
Phase |
Focus |
Design |
Identify critical functions and possible misuse scenarios |
Development |
Inform security controls, testing strategy and documentation |
Verification & Validation |
Confirm that risks are addressed and mitigations are in place |
Post-market |
Evaluate emerging threats and adapt your model for updates and field issues |
This approach also supports FDA premarket submissions and risk management files.
Key Threats to Consider
Some threats go beyond IT security. We help you explore scenarios such as:
- Loss of therapy delivery
- Triggering of unsafe device states
- Wireless signal interference
- Remote reconfiguration of critical parameters
- Lateral movement from cloud/backend systems
How We Work
This follows the same 5-step model as our standard threat modeling, but tailored to medical use cases, risk categories and applicable standards.
Want to discuss how this applies to your device? Contact us →
Used by Medical Teams For
- FDA and MDR premarket submission support
- Embedded/connected system design
- Wireless/Bluetooth security validation
- Cloud integration reviews
- IEC 62304 and ISO 14971 compliance mapping
Talk to an expert
Would you like to learn more about Medical Device Threat Modelling for your organization? Fill out the form below and we will contact you within one business day.
Related Services
Design Review
Threat Modeling Training
In the Threat Modeling Training, you will learn how to get a broad picture of potential risks using the STRIDE methodology. This works both for existing systems and new designs.
Why choose Bureau Veritas Cybersecurity
Bureau Veritas Cybersecurity is your expert partner in cybersecurity. We help organizations identify risks, strengthen defenses and comply with cybersecurity standards and regulations. Our services cover people, processes and technology, ranging from awareness training and social engineering to security advice, compliance and penetration testing.
We operate across IT, OT and IoT environments, supporting both digital systems and connected products. With over 300 cybersecurity professionals worldwide, we combine deep technical expertise with a global presence. Bureau Veritas Cybersecurity is part of the Bureau Veritas Group, a global leader in testing, inspection and certification.