Blue Goat Cyber logoBlue Goat CyberSMMedical Device Cybersecurity
    ⌘K
    Guides · Threat Modeling

    Threat Modeling guides.

    Every guide we've published on Threat Modeling.

    Format

    5 guides tagged Threat Modeling

    Threat Modeling article cover: 12 Critical Threat-Modeling Gaps in Submissions
    Threat ModelingReference

    12 Critical Threat-Modeling Gaps in Submissions

    Where threat models fall short of FDA expectations under the 2026 cybersecurity guidance - and how to fix the gaps.

    Read the guide
    Threat Modeling article cover: FDA-Grade Medical Device Threat Model: Template & Worked Example
    Threat ModelingPlaybook

    FDA-Grade Medical Device Threat Model: Template & Worked Example

    Step-by-step template to build a threat model FDA reviewers will accept - architecture views, STRIDE, safety mapping, control traceability, and a worked example.

    Read the guide
    Cover image for Patient-Safety-First Threat Modeling Guide
    Threat ModelingReference

    Patient-Safety-First Threat Modeling Guide

    Patient-Safety Threat Modeling Worksheet A right-sized STRIDE pass that maps cybersecurity threats to ISO 14971 hazards.

    Read the guide
    Cover image for Right-Sized Threat Modeling for MedTech
    Threat ModelingReference

    Right-Sized Threat Modeling for MedTech

    250+ 0 6–10 wk FDA submissions supported Cybersecurity rejections Class II eSTAR cyber pack SINCE 2014 TRACK RECORD TYPICAL TIMELINE

    Read the guide
    Cover image for STRIDE Threat Modeling for Medical Devices
    Threat ModelingReference

    STRIDE Threat Modeling for Medical Devices

    Master STRIDE threat modeling for medical devices. Learn to identify risks, meet FDA premarket requirements, and secure your MedTech ecosystem. Read our guide.

    Read the guide
    Put the guides into action

    Bring this rigor to your next submission.

    Book a 30-minute strategy session and we'll map the guides to your actual device, timeline and gaps.