Blue Goat CyberBlue Goat CyberSMMedical Device Cybersecurity
    ⌘K
    Free Guides

    Cybersecurity guides for MedTech teams.

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

    Format

    43 guides

    Standards article cover: MedTech Cybersecurity Primer for Busy Founders
    StandardsReference

    MedTech Cybersecurity Primer for Busy Founders

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

    Read the guide
    Vendor Selection article cover: MedTech Cybersecurity Vendor Evaluation Grid
    Vendor SelectionReference

    MedTech Cybersecurity Vendor Evaluation Grid

    MedTech Cyber Vendor Evaluation Grid A scoring grid for cybersecurity firms tailored to MedTech regulatory needs.

    Read the guide
    Vendor Selection article cover: MSA Redlines Playbook for MedTech Cyber Vendors
    Vendor SelectionPlaybook

    MSA Redlines Playbook for MedTech Cyber Vendors

    MSA Redlines: Usually Accepted vs. Not A short playbook for the redlines we see most often, what we accept without negotiation, and what we push back on and why.

    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
    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.

    Read the guide
    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.

    Read the guide
    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.

    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
    FDA article cover: Section 524B Post-Market Retrofit Guide
    FDAReference

    Section 524B Post-Market Retrofit Guide

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

    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.