Blue Goat CyberBlue Goat CyberSMMedical Device Cybersecurity
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    Free Guides

    Cybersecurity guides for MedTech teams.

    Practical playbooks, checklists and decoders we use on every engagement.

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    66 guides

    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.

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    Cover image for PCCP Template & Worked Example for AI/ML Medical Devices
    AI/MLPlaybook

    PCCP Template & Worked Example for AI/ML Medical Devices

    How to write a Predetermined Change Control Plan FDA will accept - structure, the three required components, performance bounds, and a worked example.

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    Pen Testing article cover: Penetration Test Refresh Guide
    Pen TestingReference

    Penetration Test Refresh Guide

    Pen Test Refresh vs. Full Re-Test Decision Guide When a delta-only refresh is sufficient, and when FDA expects a full re-test.

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    Cover image for Penetration Testing Scope for FDA Submissions: A 510(k) / De Novo / PMA Guide
    Penetration TestingReference

    Penetration Testing Scope for FDA Submissions: A 510(k) / De Novo / PMA Guide

    How to scope penetration testing for an FDA submission so the report holds up under reviewer scrutiny. Required attack surfaces, evidence depth, and how scope differs by pathway.

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    Cover image for Postmarket Cybersecurity Readiness Plan
    PostmarketPlaybook

    Postmarket Cybersecurity Readiness Plan

    What you need in place after clearance to satisfy FDA postmarket expectations and stay ahead of vulnerabilities.

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    Cover image for Postmarket SBOM Maintenance for Medical Devices
    PostmarketReference

    Postmarket SBOM Maintenance for Medical Devices

    How to maintain SBOMs across a fleet of cleared devices - regeneration cadence, vulnerability triage, VEX, and the postmarket cybersecurity plan that ties it together.

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    Cover image for Premarket FDA Cybersecurity Submission Checklist (2026)
    ChecklistChecklist

    Premarket FDA Cybersecurity Submission Checklist (2026)

    A printable, item-by-item checklist for the cybersecurity content of an FDA premarket submission - aligned to the February 2026 final guidance.

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    FDA article cover: Re-Engagement Sequence: Restarting a Stalled Cyber Program
    FDAReference

    Re-Engagement Sequence: Restarting a Stalled Cyber Program

    Re-Engagement Sequence (After Going Dark) A plain, no-pressure sequence to re-open a cybersecurity conversation after a quiet period.

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    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

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