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    Blue Goat Cyber

    Full-service medical device cybersecurity. We protect patients by securing connected medical devices from design through postmarket.

    275+ FDA submissions supported, zero cybersecurity rejections · Mission: 1,000 by 2028

    SDVOSB · Service-Disabled Veteran-Owned Small Business

    We sponsor 10 community projects →

    Services

    • FDA Premarket Cybersecurity Package
    • FDA Deficiency Response
    • Medical Device Threat Modeling
    • Medical Device Penetration Testing Services
    • FDA Postmarket Cybersecurity
    • All services →
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    • FDA Premarket Cybersecurity Package
    • FDA Deficiency Response
    • Medical Device Threat Modeling
    • Medical Device Penetration Testing Services
    • FDA Postmarket Cybersecurity
    • All services →

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    • info@bluegoatcyber.com
    • 844-939-GOAT
    • Book a strategy session →
    • 1776 N Scottsdale Rd, Unit 727
      Scottsdale, AZ 85257Serving clients worldwide

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    MedTech Cybersecurity · Since 2022

    Contact

    Let's talk about your device.

    Book a free 30-minute strategy session - or send a note and we'll get back to you within one business day.

    Send us a message

    Please do not include confidential device details. We can sign an NDA before you share them.

    Discovery Session · 30 min

    Don't see a slot that works? We have additional availability and can accommodate any time zone - we work with clients across North America, Europe, the Middle East, and Asia-Pacific. Email us and we'll find a time.

    Call or email us

    • Email
      info@bluegoatcyber.com
    • Phone
      +1 (844) 939-4628
    • LinkedIn
      @blue-goat-cyber
    • Mailing address
      1776 N Scottsdale Rd, Unit 727
      Scottsdale, AZ 85257
      Based in the Phoenix area, serving Arizona and clients worldwide. Meetings by video call.

    What to expect

    • • 30-minute discovery call
    • • Honest assessment of your regulatory path
    • • Initial cybersecurity triage within 24 hours
    • • Quote / proposal delivered within 24 hours
    • • Fixed-fee proposal - no surprises
    Book session →

    How to prepare

    A few things that make the call productive

    No prep required, but if you can speak to these we'll give you sharper answers in the same 30 minutes:

    • Your product's technical complexity
      Connectivity (BLE, Wi-Fi, cellular), cloud backend, mobile app, AI/ML, third-party SDKs.
    • A high-level system overview
      Even a whiteboard sketch or block diagram helps us scope accurately.
    • Regulatory needs, timeline, and pathway
      510(k), De Novo, PMA, EU MDR/IVDR - and your target submission date.
    • NDA before the call?
      Happy to sign yours - email it to info@bluegoatcyber.com and we'll turn it around before we meet.
    Before you reach out

    Contact FAQs

    What happens after you send a note, how NDAs work, and how we handle urgent timelines.

    In their words

    Backed by MedTech leaders.

    HT
    "Blue Goat Cyber's depth of expertise was impressive. We had no in-house cybersecurity experience, and their team guided us through every step of the FDA process. The penetration testing and SBOM testing were thorough and gave us complete confidence."
    Hank Tucker
    CEO · MedTech Manufacturer
    Scott Odland, Solutions Architect at Rhaeos
    "Blue Goat's niche expertise in FDA-facing cybersecurity made all the difference. Their reports were built with the FDA's expectations in mind; it gave us confidence that we were submitting exactly what reviewers want to see."
    Scott Odland
    Solutions Architect · Rhaeos
    Tim Sandberg, VP of IT Operations at Matrix One
    "The timeliness of this project exceeded my expectations - this was not my experience with other vendors. Blue Goat Cyber delivered a thorough, detailed report and complete testing faster than I anticipated, without compromising quality."
    Tim Sandberg
    VP of IT Operations · Matrix One