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.

    Format

    42 guides

    FDA article cover: Cyber Device Decision Tree (Are You In Scope of 524B?)
    FDAReference

    Cyber Device Decision Tree (Are You In Scope of 524B?)

    Is Your Device a 'Cyber Device'? A Decision Tree Walk through Section 524B's three-part test in five minutes.

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    Standards article cover: Cyber Insurance Limits Guide for MedTech
    StandardsReference

    Cyber Insurance Limits Guide for MedTech

    Insurance Limits: Standard vs. Enterprise Match Cyber, E&O, and product-liability limits we carry, and how they typically compare to enterprise procurement asks.

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    Standards article cover: Cybersecurity in a QMS-in-Flux Environment
    StandardsReference

    Cybersecurity in a QMS-in-Flux Environment

    Cybersecurity When Your QMS Is in Flux How to keep cyber moving while you migrate from 21 CFR 820 to QMSR or build a QMS for the first time.

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    Standards article cover: Dev Team vs. Cybersecurity Roles Playbook
    StandardsPlaybook

    Dev Team vs. Cybersecurity Roles Playbook

    Dev Team vs. Cybersecurity Team: Roles & Responsibilities Playbook A clear RACI for the artifacts FDA expects in a Section 524B submission.

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    Cover image for FDA Classification Decision Tree (Wellness vs. Device)
    FDAReference

    FDA Classification Decision Tree (Wellness vs. Device)

    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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    Cover image for FDA Cybersecurity Deficiency Response Checklist
    FDAChecklist

    FDA Cybersecurity Deficiency Response Checklist

    Step-by-step checklist for responding to FDA cybersecurity deficiency letters without losing your submission timeline.

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    Cover image for FDA Cybersecurity Readiness Diagnostic Outline
    FDAReference

    FDA Cybersecurity Readiness Diagnostic Outline

    20-Minute Cyber Readiness Diagnostic Outline The exact agenda we run on a 20-minute discovery call so it produces a usable output.

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    Cover image for FDA Cybersecurity Submission Requirements Guide
    FDAReference

    FDA Cybersecurity Submission Requirements Guide

    FDA Cyber Requirements: The Law, the Guidance, the eSTAR A precise reference for what Section 524B requires and what the Feb 3, 2026 guidance expects.

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    Cover image for FDA Submission Cybersecurity Readiness Audit
    FDAReference

    FDA Submission Cybersecurity Readiness Audit

    Submission Readiness Self-Audit A pre-submission self-check covering every cyber attachment FDA expects.

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