275+ devices supported. No cybersecurity-related rejections to date. One senior team handling threat modeling, SBOM, pen testing, and submission - with retests until every finding is closed.
If the FDA raises cybersecurity deficiencies on work we delivered, we resolve them at no additional cost to you.
We commit to the work, not to the FDA's decision. Clearance rests with the FDA and depends on factors beyond cybersecurity.
A transparent, side-by-side look at what you actually get - no vague promises.
| Capability | Blue Goat Cyber ★ Recommended | Typical Vendor(industry average) |
|---|---|---|
1 Technical Capabilities The hands-on cybersecurity work that gets your device cleared. | ||
12+ Years Exclusively Testing Medical Devices Refined, MedTech-specific process - not a generic pentest checklist retrofitted for healthcare. | ||
Medical Protocol Testing (DICOM, HL7/FHIR, MedRadio, BLE Medical) Specialized protocols with their own attack surface; most vendors lack the tooling or expertise. | ||
Penetration Testing (Device + Cloud/Mobile) Most competitors test only the device, not the full ecosystem. | ||
Wireless / Bluetooth / RF Security Testing Critical for connected devices, often limited or scoped out. | ||
Cloud Backend & Mobile Companion App Testing AWS/Azure/GCP plus iOS/Android companion apps. | ||
Protocol Fuzzing & Hardware/Firmware Analysis Bus sniffing, JTAG/UART, firmware extraction, and protocol fuzzing - beyond standard IT pentesting. | ||
Patient-Safety Driven (ISO 14971 ↔ Cybersecurity) Cyber risk tied to patient harm, not just data - IT vendors miss this entirely. | ||
Threat Modeling (STRIDE / Attack Trees) | ||
SBOM Generation & Management | ||
Static Application Security Testing (SAST) | ||
Postmarket Vulnerability Monitoring Continuous monitoring with our GoatWatch platform. | ||
ISO 13485 Quality System Alignment Cybersecurity deliverables map cleanly into your existing ISO 13485 QMS - no parallel paperwork. | ||
Time to First Deliverable Kickoff to first artifact in ~5 days, vs. 4-6 weeks at most firms. | ||
2 FDA Submission Support What actually moves your submission across the finish line. | ||
FDA Premarket Cybersecurity Documentation Full Section 524B submission package, eSTAR-ready. | ||
FDA 2026 Premarket Cybersecurity Guidance Aligned Feb 3, 2026 guidance: SPDF, Section 524B, threat modeling, SBOM, security architecture views. Most are still catching up. | ||
AAMI SW96 (Medical Device Security Standard) The new consensus standard FDA increasingly references. | ||
Dedicated FDA Submission Support We've never had an FDA cyber rejection. | ||
Deficiency Letter & RTA Response | ||
EU MDR / IVDR Submissions MDCG 2019-16 alignment for EU market submissions. | ||
FDA RTA / Deficiency Response Turnaround Same-week turnaround on FDA cyber deficiency letters - included, no change orders. | ||
3 Business Terms How we work, and why it removes risk for you. | ||
FDA Cybersecurity Deficiency Commitment If FDA pushes back on cyber, we keep working at no extra cost until the deficiency is resolved. | ||
Retests Included Retests until every finding is closed, with no per-retest invoices. | ||
275+ Devices Successfully Cleared Track record across startups to Intuitive Surgical, bioMérieux, Inogen, Natera. | ||
Senior Expert Leads Your Engagement Boutiques sometimes do this; large firms typically hand the work to juniors after the partner pitch. | ||
Service-Disabled Veteran-Owned (SDVOSB) Federally certified - advantageous for federal MedTech contracts. | ||
Full-Service (No Subcontractors) Many vendors subcontract specialized testing; we keep it in-house. | ||
Fixed-Fee Pricing Some offer fixed-fee; many bill T&M with scope creep. | ||
Start This Week (Not Next Quarter) Agile team, defined processes, no onboarding queue. | ||
Post-Submission Support Included We stay with you through FDA review - no extra invoices for follow-up questions. | ||
Get a fixed-fee quote and a clear scope from a senior expert in 24 hours.
Schedule discovery sessionJust want to compare us to a specific vendor? Book a 15-min comparison call.
"Blue Goat didn't just test our device - they became an extension of our regulatory team. Our submission sailed through with zero cybersecurity deficiencies."
"We switched mid-project. Blue Goat found critical vulnerabilities the previous vendor missed and helped us remediate in half the time we expected."
Most vendors talk about credentials. We talk about devices cleared, deadlines hit, and submissions accepted.
From Class I to Class III, across surgical, diagnostic, and connected devices.
Every artifact in your cybersecurity package is produced by our senior US-based team, never subcontracted.
From discovery call to scoped proposal - no drawn-out sales cycles.
We don't stop testing until your device passes - at no extra cost.
A snapshot of recent engagements - from Fortune 500 MedTech to pre-seed startups.
Complex Class II connected device requiring full FDA cybersecurity package under updated guidance.
Cleared on first FDA review with zero cybersecurity-related deficiencies.
Bluetooth-enabled wearable requiring SBOM, threat model, and penetration testing for 510(k) submission.
Full cybersecurity documentation delivered in 6 weeks, submission accepted without RTA hold.
Pre-seed company with no internal security team needed end-to-end FDA cybersecurity readiness.
Full program built from scratch, device cleared, company raised Series A on the strength of regulatory progress.
Most vendors put you in a 4-to-8-week onboarding queue. We start this week.
Talk directly with a senior practitioner. We learn your device, submission timeline, and risk profile. No sales reps, no qualification gauntlet.
You receive a clear scope, deliverables list, timeline, and fixed price. No hourly billing, no surprises, no scope creep.
Our agile team starts immediately. Weekly syncs, shared workspace, and rapid feedback loops keep your regulatory team in the loop.
Threat model, SBOM, pen test report, and full submission package delivered on time. Backed by our FDA cybersecurity deficiency commitment.
Medical device cybersecurity is 100% of what we do. Every Blue Goat engagement is built around the Secure Product Development Framework (SPDF) and Section 524B requirements from FDA's February 3, 2026 final guidance.
Threat modeling, cybersecurity risk assessment, interoperability, third-party software (SBOM + VEX), unresolved anomalies, and TPLC risk management.
Global system, multi-patient harm, updateability/patchability, and security use case views, with documented security controls per Appendix 1.
Security requirements, threat mitigation, vulnerability, and penetration testing - with evidence reviewers can validate.
Plans to monitor, identify, and address postmarket vulnerabilities; SPDF processes; and a software bill of materials (SBOM).
One senior team handles every aspect of your cybersecurity, so you can focus on building life-saving devices.
Complete Secure Product Development Framework aligned with FDA expectations and AAMI TIR57.
Explore SPDF DevelopmentComprehensive Software Bill of Materials for full supply-chain transparency and lifecycle monitoring.
Explore SBOM GenerationSystematic identification of realistic abuse cases tied to safety and effectiveness impacts.
Explore Threat ModelingDeep vulnerability assessment with remediation and retest evidence.
Explore Penetration TestingSubmission-ready cybersecurity documentation organized for fast FDA reviewer validation.
Explore eSTAR DocumentationFix cybersecurity deficiency issues fast, with experts who've done it hundreds of times.
Explore FDA Deficiency ResponseFDA + SOC 2 + HIPAA + HITRUST + GDPR run in parallel on one control set - so hospital procurement and EU review don't block launch after clearance.
Explore MedTech Compliance BundleContinuous patching, monitoring, and reporting after clearance, including legacy device protection.
Explore Postmarket ComplianceSix commitments competitors won't put in writing.
If FDA cites a cybersecurity deficiency in a deliverable we produced, we fix it at no additional cost. To date, we've had no cybersecurity-related rejections across 275+ devices. We commit to the work, not to the FDA's decision.
We scope it, we price it, we deliver it. No hourly billing that balloons. No change orders for "unexpected complexity."
Cybersecurity isn't a one-shot deal. Retests are included until every finding is closed, within your fixed fee.
Every engineer on your project is US-based and works exclusively for Blue Goat. No offshore handoffs, no shared resources, no surprises about who's touching your device.
GoatWatch (our SBOM management platform) and our client collaboration portal are included, not upsold. Securing medical devices since 2014 means we built the tools competitors still don't have.
Founder Christian Espinosa's life was saved by a medical device. Securing them isn't a service line for us - it's why we exist.
30 minutes · No cost · Senior expert on the call
Our team holds the offensive security certifications real attackers respect - backed by hands-on U.S. government red team and military cyber operations experience.
Our work has been honored by leading voices in medical device cybersecurity.
Sponsored by the Malta Medicines Authority.
Inaugural North America Awards, in collaboration with CS Lifesciences - recognition of our patient-safety-first approach to FDA cybersecurity submissions.
Cover story profiling Blue Goat Cyber as a top industry leader.
Two practical PDFs you can use today - no email required.
A practical buyer's scorecard for manufacturers - with a timeline reality check and what to demand in a fixed-fee SOW.
Side-by-side scorecard you can print and walk into a vendor evaluation with - covering tech, FDA, and business terms.
No email required.
The questions that come up most when teams compare us to general cybersecurity firms.
"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."
The comparison above is about method. This is about why the method exists in the first place.
Medical device security is patient safety.
Why we exist: so the devices people depend on can't be turned against them.
Connected medical devices that are secure by design and resilient for their entire service life.
The world we are working toward, with no end date.
By 2028, help medical device teams get 1,000 devices through FDA review with zero cybersecurity-driven rejections, and teach the industry to start cybersecurity early.
What we do daily, with a deadline: secure the devices in front of us, and through books, stages, podcasts, webinars, and mentoring, help every other team understand what cybersecurity means for their device before it costs them.
Get a fixed-fee quote and a clear scope from a senior expert in 24 hours.
