For medtech startups

    Your first FDA cybersecurity submission, scoped at a fixed fee

    If your device has software and can connect, the FDA will expect a threat model, SBOM, security testing, and a postmarket plan. Tell us about your device and we'll scope the work.

    What the package covers

    • Threat model and cybersecurity risk assessment
    • Architecture views
    • SBOM with known-vulnerability review
    • Penetration testing, with retests until uncontrolled risks are closed
    • Postmarket vulnerability plan
    • Submission documentation mapped to eSTAR

    How it works

    1. 1

      Send the form

      Tell us about your device and when you plan to file.

    2. 2

      Short scoping call

      We learn the architecture, interfaces, and what already exists.

    3. 3

      Fixed-fee scope

      You get a written fixed-fee scope within 24 hours of the call.

    Fixed fee, a project manager, a shared Slack channel, and in-house testing. 275+ FDA submissions supported, zero cybersecurity rejections. Penetration tests are quoted at a fixed fee after scoping.

    Still planning? Read medical device cybersecurity for startups or the early-stage readiness checklist.

    Get my fixed-fee scope

    Tell us about your device and target filing date. We reply within one business day and send a fixed-fee scope within 24 hours of a short scoping call.

    Or skip the form - book a strategy session →

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