Blue Goat CyberBlue Goat CyberSMMedical Device Cybersecurity
    ⌘K
    Stage 2 · ~9 months out

    Manual penetration testing and the premarket evidence package

    Submission is on the calendar - you have time to get it right

    Pre-submission is when reviewers' future questions are answered or buried. Start ~9 months before your 510(k), De Novo, or PMA goes in so manual pen testing, the threat model, the SBOM, security architecture views, and the Section 524B narrative all land in eSTAR together - coherent, traceable, and reviewer-tested.

    1. Stage 1Concept & Design
    2. Stage 2Pre-Submission
    3. Stage 3FDA Submission
    4. Stage 4FDA Response
    5. Stage 5Postmarket
    What we deliver

    How we move you through pre-submission

    • Manual penetration testing across hardware, firmware, BLE/RF, mobile, and cloud
    • Reviewer-ready threat model, SBOM, and security architecture views
    • Section 524B evidence package mapped to FDA's Feb 2026 guidance
    • Findings remediated and re-tested before the package ships
    Recommended next steps

    Services that fit this stage

    Premarket

    Medical Device Penetration Testing

    Hardware, firmware, mobile, and cloud - tested by operators with both red-team and medical-device experience. Reports built for FDA reviewers.

    Explore service     Premarket

    BLE & RF Penetration Testing

    À la carte wireless interface testing for medical devices - BLE pairing, GATT enumeration, Wi-Fi association, NFC/RFID, and proprietary RF protocol fuzzing. Reviewer-ready evidence for FDA premarket and EU MDR submissions.

    Explore service     Premarket

    Firmware Penetration Testing

    À la carte firmware testing for embedded medical devices - extraction via JTAG/SWD/UART or chip-off, binary analysis, secure boot validation, and OTA update path testing. Findings traceable to your SBOM and threat model.

    Explore service     Premarket

    PHI Cloud Backend Penetration Testing

    À la carte cloud backend testing for connected medical devices - AWS/Azure/GCP infrastructure, device-to-cloud APIs, IAM and tenant isolation, PHI data flows, and HIPAA-aligned controls. Reviewer-ready for FDA submissions and SOC 2 evidence.

    Explore service
    ← Previous stage

    Concept & Design

    While you're still designing the device

    Next stage →

    FDA Submission

    510(k), De Novo, or PMA goes to FDA

    Stage 2 · ~9 months out

    Ready to take on pre-submission?

    Free 30-minute strategy session with a senior MedTech cybersecurity expert. No cost, no commitment.