Why does Blue Goat Cyber organize by medical device segment?

Cyber risk is shaped by the device's clinical use, connectivity, and patient-harm profile. Segment-specific landing pages let us show the threat models, standards, and FDA expectations that actually apply to your device class.

What if our device crosses multiple segments?

That's normal - a closed-loop AID system spans diabetes, wearables, and SaMD. We model the device against every applicable segment's risks and consolidate them into a single SPDF.

Do you support segments that aren't listed?

Yes. We exclusively serve medical device manufacturers, and we've supported devices well outside the segments shown here. Reach out and we'll build the threat model for your specific class.

How is the engagement priced and how long does it take?

Fixed-fee, scoped after a free 30-minute Discovery Session. Most premarket engagements (penetration testing, threat modeling, SBOM, deficiency response) complete in 4–8 weeks. We typically start within 1–2 weeks of contract signature.

What if the FDA still pushes back after we submit?

We back our work with a 100% success guarantee. If your submission is delayed because of a cybersecurity deficiency in our deliverables, we resolve it at no additional cost until your device is cleared.