Threat Model Starter: frequently asked questions

What's in the starter guide

What do I get when I download the STRIDE starter guide?

A printable guide built from your answers: a simple diagram of your system and its trust boundaries, a table of entry points, STRIDE threats for each connection with likely attacks, a patient-harm level, and suggested fixes, plus a short checklist of what the FDA expects next.

What do I need to enter?

Device name and purpose, who uses it, your FDA pathway, the connections it has (Bluetooth, Wi-Fi, cellular, USB, cloud, and so on), the data and functions to protect, the worst patient harm, how updates reach the device, and any protections you already have. It takes about five minutes.

Should I enter confidential design details?

No. The tool only needs general answers, like which connections exist and what could go wrong for a patient. Don't enter part numbers, source code, keys, or unreleased product names you want kept private.

Why does it ask for a work email?

The download is free, and the email is how we know who's using it. We don't sell or rent it. Our privacy policy covers the rest.

Is the guide the same as the insulin pump example on your STRIDE guide?

It follows the same layout: diagram, entry points, and STRIDE threats per connection. The pump example goes deeper because a person wrote it for one specific system. Your starter guide is generated from a fixed list of common threats.

How it differs from a submission-ready threat model

Can I submit the starter guide to the FDA?

No. It's a starting point, not a submission-ready threat model. It helps you see your attack surface and organize your thinking before the real work begins.

What does a submission-ready threat model have that the starter doesn't?

A full system diagram drawn from your actual design, every interface and data flow, threats specific to your hardware and software, written reasoning for each rating, traceability to your ISO 14971 risk file and design requirements, links to test evidence, and a record of how the model is kept up to date after clearance.

Why isn't a generic list of threats enough?

Reviewers want to see why each threat applies to your device, how you rated it, and which control addresses it. A list that could fit any device doesn't show that, and missing reasoning is a common reason for FDA questions.

How does the starter guide relate to ThreatGoat?

ThreatGoat is our paid software for building and maintaining a full threat model and risk assessment. The starter guide is a quick first look. Many teams use the starter to get oriented, then build the full model in ThreatGoat.

We already have a threat model. Is the starter useful?

Probably not. If you have a model, our threat model gap assessment is a better fit. We review your existing model and hazard analysis and give you a list of gaps ranked by priority.

Why it's free

Why do you give this away?

Most teams we talk to are unsure where to start. A free starting point helps them understand what the FDA expects, and some of them later hire us or use ThreatGoat for the full work.

Is there a catch?

No payment, no trial, and no account. You enter a work email to download the guide. You can use it however you like inside your company.

Will someone call me?

Only if you ask. You can book a call yourself if you'd like help turning the starter into a full threat model.

Where to go next

• Threat Model Starter: build your free starter guide.
• STRIDE for medical devices: the full insulin pump example.
• Threat model gap assessment: for teams with an existing model.
• Threat modeling services: we build the submission-ready model with you.