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

    Standards article cover: SOW Line-Item Map for MedTech Cybersecurity
    StandardsReference

    SOW Line-Item Map for MedTech Cybersecurity

    SOW Line-Item Justification Map Map every line item on a typical cybersecurity SOW to the FDA artifact it produces.

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    Standards article cover: Technical Scoping Call Agenda
    StandardsReference

    Technical Scoping Call Agenda

    Technical Scoping Session Agenda + Input Checklist Ninety minutes to scope a cybersecurity engagement precisely so the SOW reflects reality.

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    Standards article cover: The MedTech Cybersecurity Funding Ask Guide
    StandardsReference

    The MedTech Cybersecurity Funding Ask Guide

    60–80% 6–10 wk 90–180 d 0 Founders underbudget cyber by Class II eSTAR cyber pack Avg. delay from a single AI letter Submissions rejected INDUSTRY AVERAGE TYPICAL TIMELINE FDA DATA BLUE GOAT TRACK RECORD

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    Cover image for The MedTech Cybersecurity Standards Decoder
    StandardsReference

    The MedTech Cybersecurity Standards Decoder

    FDA Section 524B, IEC 81001-5-1, AAMI TIR57, ISO 14971 and more - what they require, how they connect, and what the FDA expects to see.

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    Cover image for The SPDF Playbook
    SPDFPlaybook

    The SPDF Playbook

    A practical playbook for implementing the Secure Product Development Framework across your QMS and SDLC.

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    Standards article cover: Total Product Life Cycle (TPLC) Cyber Timing Guide
    StandardsReference

    Total Product Life Cycle (TPLC) Cyber Timing Guide

    The TPLC Cybersecurity Timing Guide Why FDA's Total Product Life Cycle framework makes 'later' the most expensive answer in medical-device development.

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    Put the guides into action

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