Which services should we start with for an FDA submission?

Most premarket programs combine threat modeling, an SBOM, and penetration testing - all packaged against the FDA's 2026 premarket guidance and ANSI/AAMI SW96. We map the right starting point in the Discovery Session.

Can we engage you for just one piece, like pen testing or SBOM?

Yes. Every service is scoped and priced as a standalone engagement with a fixed fee, so you can pull in only the piece you need - or layer them into a full SPDF program.

Do you only work on premarket, or also postmarket?

Both. Premarket: pen testing, threat modeling, SBOM, deficiency response, secure-by-design. Postmarket: GoatWatch monitoring, patch and vulnerability management, legacy device cybersecurity, and CVD program support.

How do you keep services consistent across a multi-device portfolio?

We standardize the SPDF artifacts (threat model, SBOM, test plan, traceability) so they reuse cleanly across families of devices - only the device-specific risks and surfaces change.

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 no-cost deficiency resolution commitment. If your submission is delayed because of a cybersecurity deficiency in our deliverables, we resolve it at no additional cost until that deficiency is closed. We cannot and do not guarantee clearance itself - that is the FDA's decision.

Services

Cybersecurity for every stage of your device lifecycle.

Cleared by the FDA, approved by the hospital. Premarket through postmarket, one team, one accountable partner for medical device cybersecurity. Fixed-fee pricing, FDA-ready deliverables.

Start here

Find the right service in two questions

1. Where is your device right now?

Most requested

Full-Service FDA Premarket Cybersecurity

Full-service: we own 100% of SPDF, SBOMs, threat modeling, pen testing, and eSTAR documentation.

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Most requested

Medical Device Penetration Testing

FDA-compliant device, firmware, app, and cloud testing.

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Start here: FDA cybersecurity

One overview of how Section 524B evidence, submission support, penetration testing, deficiency response, and postmarket monitoring fit together - with pricing and engagement models.

See the full lifecycle

Services by where you are

Find your situation, then the services that solve it.

Designing the device

“We need security built in before the FDA asks for it.”

Medical Device Threat Modeling

FDA-aligned threat models that identify risks early and speed approvals.

Explore Medical Device Threat Modeling

Secure MedTech Product Design

Bake cybersecurity into your device from day one.

Explore Secure MedTech Product Design

Getting ready to submit

“We need a complete, FDA-ready cybersecurity package.”

Full-Service FDA Premarket Cybersecurity

Full-service: we own 100% of SPDF, SBOMs, threat modeling, pen testing, and eSTAR documentation.

Explore Full-Service FDA Premarket Cybersecurity

Medical Device Penetration Testing

FDA-compliant device, firmware, app, and cloud testing.

Explore Medical Device Penetration Testing

FDA-Compliant SBOM Services

Create, validate, and maintain SBOMs for premarket and postmarket.

Explore FDA-Compliant SBOM Services

Got an FDA deficiency letter

“The FDA flagged our cybersecurity and the clock is ticking.”

FDA Deficiency Response

Got an FDA hold or AI letter? We close cybersecurity deficiencies fast.

Explore FDA Deficiency Response

Passing hospital security reviews

“Hospitals won't buy until we pass their security review.”

MedTech Compliance Bundle

One program covering FDA Clearance, SOC 2, HIPAA, HITRUST, and GDPR - run in parallel for hospital-ready and EU-ready launch.

Explore MedTech Compliance Bundle

HIPAA Penetration Testing

Penetration testing scoped to HIPAA Security Rule expectations.

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Already on the market

“We need to stay compliant and handle new vulnerabilities.”

FDA Postmarket Cybersecurity

Continuous compliance, monitoring, and vulnerability response.

Explore FDA Postmarket Cybersecurity

Legacy Device Protection

Reduce risk on fielded devices - no redesign, no new submission, no downtime.

Explore Legacy Device Protection

Also: How this stage works, GoatWatch SBOM monitoring

GoatWatchby Blue Goat Cyber

Stay ahead of CVEs. Audit-ready always.

Continuous SBOM monitoring for medical devices. Daily CVE matching, device-context triage, and VEX-ready evidence aligned to FDA Section 524B - without the noise.

Daily CVE MatchingDevice-Context TriageVEX-Ready Evidence

Explore GoatWatch bluegoatcyber.com/products/goatwatch

Live MonitoringACTIVE

Devices Supported: no cybersecurity-related rejections to date
Section 524B: Postmarket ready
Setup: Fixed-fee

FAQ

Common questions about our services

How engagements are scoped, sequenced, and priced - straight answers from a senior team.

In their words

Backed by MedTech leaders.

"Blue Goat Cyber's depth of expertise was impressive. We had no in-house cybersecurity experience, and their team guided us through every step of the FDA process. The penetration testing and SBOM testing were thorough and gave us complete confidence."

Hank Tucker

CEO · MedTech Manufacturer

Pick the right starting point

Not sure which service you need?

A 30-minute scoping call gets you a recommended package and a fixed-fee SOW - no hourly meters, no surprises.

Scope my engagement See methodology