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

    59 guides

    Standards article cover: "Let Me Think About It" Diagnostic for Stalled Deals
    StandardsReference

    "Let Me Think About It" Diagnostic for Stalled Deals

    Diagnostic Questions for 'Let Me Think About It' A short diagnostic to surface the real concern when a decision is parked.

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    Vendor Selection article cover: 10 Reasons Cybersecurity Vendors Fail MedTech
    Vendor SelectionReference

    10 Reasons Cybersecurity Vendors Fail MedTech

    Why generic IT-security vendors keep blowing FDA submissions - and what to demand from a true MedTech specialist.

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    Pen Testing article cover: 12 Critical Findings from Medical Device Pen Tests
    Pen TestingReference

    12 Critical Findings from Medical Device Pen Tests

    Real, recurring vulnerabilities we uncover during penetration testing on Class II/III connected medical devices.

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    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.

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    Cover image for 12 Reasons the FDA Rejects Cybersecurity Submissions
    FDAReference

    12 Reasons the FDA Rejects Cybersecurity Submissions

    The most common deficiencies we see in 510(k), De Novo, and PMA cybersecurity packages - and how to avoid each one.

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    Cover image for AAMI TIR57 vs TIR97: Comparing Redetec Standards
    StandardsReference

    AAMI TIR57 vs TIR97: Comparing Redetec Standards

    Compare AAMI TIR57 vs TIR97. Learn how these cybersecurity risk management standards differ and how to apply them for FDA premarket and postmarket compliance.

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    Standards article cover: Board-Ready Cybersecurity 1-Pager + Pre-Read
    StandardsReference

    Board-Ready Cybersecurity 1-Pager + Pre-Read

    Board-Ready 1-Pager + Pre-Read Pack When the board asks 'are we covered on cyber?', this is the answer in one page.

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    Standards article cover: Budget-Aware Engagement Structures
    StandardsReference

    Budget-Aware Engagement Structures

    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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    Standards article cover: Cloud-Only MedTech Threat Surface Map
    StandardsReference

    Cloud-Only MedTech Threat Surface Map

    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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