Medcrypt

Threat modeling that makes your device more secure.

Model your device against its real architecture in the methodology your team already uses, catch the design weaknesses before a pen test does, and let the submission artifact fall out of the work.

Book a threat model review

Features

Teams don't do this for the regulator.

The act of doing it is the win

Working through your architecture surfaces design weaknesses before a pen test or a field deployment finds them for you. Teams come out of the exercise with a better device, not just a better document.

Efficiency is how it scales

Scenarios and attack trees arrive drafted from your architecture instead of starting from a blank page, so one team can cover a whole portfolio without adding headcount to do it.

Compliance is the icing

Because the work is built to recognized methodologies and checked by former FDA reviewers, the submission artifact falls out of it. You do the engineering; the evidence is a by-product.

How we work with your team

Three steps, and your team keeps the last word.

You are not handing the work over. The platform does the drafting and the consistency checking; every judgment call stays with the people who know the device.

  1. Bring the documents you already have.

    You bring the architecture documents and system descriptions you already maintain. There is no new format to author first and no modelling tool to learn. Because the model is built from how the device is designed rather than from its source, it surfaces architectural weaknesses a code scan structurally cannot see.

    Documents

    Source documentStatus
    ArchitectureParsed
    InterfacesParsed
    Data flowsReading
    Extracting assets and data-flow diagram

  2. Drafted from your architecture, then checked against itself.

    Medcrypt drafts the scenarios and attack trees from that architecture, in the methodology your team already works in. Then it checks its own output: inconsistent scoring, structural gaps, and the mismatches an FDA reviewer tends to flag.

    Threat register

    IDThreatCheck
    T-001SClear
    T-002TScore
    T-003IClear
    T-004EGap

  3. Nothing lands until your team accepts it.

    The run stops for review at every stage, so nothing enters the model until your team approves it. Once you have approved a stage your judgment stands: a later run proposes changes rather than overwriting what you decided. Our former FDA reviewers check the finished model for submission-readiness.

    Threat model run

    Assets extracted
    Threats identified
    Risks scored
    Controls mappedAwaiting review
    Traceability report
    Request changesApprove stage

What you get

What lands in your hands.

Accelerated drafting

Scenarios and attack trees drafted from your architecture, in the methodology your team already works in.Explore automated threat model generation

Accuracy and consistency checks

Flags inconsistent CVSS scoring, structural gaps, and mismatches with what reviewers expect to see.

Answers in plain language

Ask questions of FDA cybersecurity guidance, vulnerability data, and threat intelligence without leaving the model.

Submission-ready export

Structured output that drops into your ISO 14971 and AAMI SW96 templates, so the threat model feeds your security risk assessment rather than sitting beside it.

Know where you are in 1 hour.

Run the free check or talk to a human. Either way, you’ll get a clearer view of readiness without a paywall or lengthy sales call.

Check readiness