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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

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    • FDA Postmarket Cybersecurity
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    MedTech Cybersecurity · Since 2022

    Prep Journey

    Make your 30-minute strategy session count.

    A short walkthrough so you arrive ready, leave with a clear scope, and don't burn a single minute on small talk.

    Start the prep journey Book strategy session ~18 min total · skim it in 3
    01 · Company02 · Device03 · Architecture04 · Artifacts05 · Outcome06 · Book it

    Don't have any of this yet? Book the call anyway.

    The steps below are aspirational - a way to get more out of the 30 minutes if you're prepared. None of them are required. We've scoped engagements from a single sentence ("we're building a Class II wearable") all the way up to a 400-page submission. Bring what exists; we'll handle the gaps.

    See the FAQ ↓

    1. Step 012 min

      Know your company snapshot

      We'll move faster if we know who you are and where you're heading. Bring a one-line description of the company and what stage you're at.

      • Company name, website, headcount
      • Funding stage (bootstrap, seed, Series A+, public)
      • Target launch market(s) - US FDA, EU MDR, both
      • Where you are in development (concept, V&V, pre-submission, cleared)
    2. Step 023 min

      Describe the device

      The more specific you are about the device, the more specific our scope and timeline will be. A short description goes a long way.

      • Intended use & patient population
      • Device classification (Class I / II / III) if known
      • Submission pathway (510(k), De Novo, PMA, EU MDR)
      • Connectivity: BLE, Wi-Fi, cellular, cloud, mobile companion app
      • Software level of concern (Basic, Enhanced)
    3. Step 035 min

      Map the architecture (one whiteboard sketch is enough)

      You don't need formal diagrams. A rough sketch of components, data flow, and external interfaces tells us 80% of what we need.

      • Device hardware (MCU/SoC, OS, key peripherals)
      • Software components: firmware, mobile app, web portal, cloud backend
      • Third-party / OSS components you depend on (rough list)
      • Where PHI / patient data lives and moves
      • Authentication and update mechanisms (if designed yet)
    4. Step 045 min

      Gather what you already have

      We don't need polished documents - drafts and outlines are perfect. Bring what exists; we'll tell you what's missing.

      • Design inputs / requirements doc (any format)
      • Risk management file or hazard analysis (ISO 14971)
      • Existing threat model, SBOM, or security architecture (if any)
      • Prior FDA correspondence (Q-Sub feedback, AI requests, deficiency letters)
      • QMS posture: ISO 13485, 21 CFR 820, internal SOPs
    5. Step 052 min

      Decide what 'success' looks like for this call

      A 30-minute call is plenty if you know what outcome you want. Pick one or two - we'll prioritize ruthlessly.

      • Fixed-fee scope and timeline for a specific submission
      • Sanity check on an upcoming Q-Sub or 510(k) cybersecurity package
      • Help responding to an FDA cybersecurity deficiency letter
      • Pen test / threat model scoping for a connected device
      • Postmarket vulnerability handling and SBOM/VEX program design
      • Strategic guidance for an upcoming round, M&A, or audit
    6. Step 061 min

      Book the call - and bring one stakeholder

      30 minutes, no slide deck on our side. Bring whoever owns the answers (regulatory lead, head of engineering, or founder) and we'll deliver a written follow-up within one business day.

      • Pick a time that works for the decision-maker
      • Loop in your regulatory or engineering lead if separate from the founder
      • Have your device sketch and any prior FDA correspondence open in another tab
      • Allow 30 minutes uninterrupted - we use every one of them
    What You'll Walk Away With

    A 30-minute call. Three concrete outputs.

    A clear scope

    Exactly what we'd do, what you'd do, and what 'done' looks like.

    A fixed fee

    Within 24 hours of the call - no hourly games, no scope creep.

    A timeline you can plan around

    Tied to your submission date, not ours.

    Quick Answers

    Before you book.

    • Yes. Plenty of founders book the call before they have a single document. If all you can answer is "we're building X and we think it's a Class II," that's enough to have a useful 30 minutes. We'll ask the questions; you don't need slides, diagrams, or a written brief.

    Prepped? Pick a time.

    30 minutes is plenty when both sides come ready. Book now and you'll have a written summary and a fixed-fee proposal in your inbox within one business day.

    Book strategy session Prefer email? Contact us