Get FDA cybersecurity clearance. Guaranteed. Fixed-fee.
250+ devices cleared. 100% FDA success rate. One senior team handling threat modeling, SBOM, pen testing, and submission - with unlimited retests until you clear.
- Free 30-min call
- No obligation
- Senior expert on call
- Fixed-fee quote in 24 hours
- NDA available on request
If FDA raises cybersecurity deficiencies after our submission, we resolve them at no additional cost to you.
How Blue Goat Cyber stacks up.
A transparent, side-by-side look at what you actually get - no vague promises.
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Blue Goat Cyber ★ Recommended
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Typical Vendor(industry average)
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1
Technical Capabilities
The hands-on cybersecurity work that gets your device cleared.
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12+ Years Exclusively Testing Medical Devices
Refined, MedTech-specific process - not a generic pentest checklist retrofitted for healthcare.
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Medical Protocol Testing (DICOM, HL7/FHIR, MedRadio, BLE Medical)
Specialized protocols with their own attack surface; most vendors lack the tooling or expertise.
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Penetration Testing (Device + Cloud/Mobile)
Most competitors test only the device, not the full ecosystem.
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Wireless / Bluetooth / RF Security Testing
Critical for connected devices, often limited or scoped out.
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Cloud Backend & Mobile Companion App Testing
AWS/Azure/GCP plus iOS/Android companion apps.
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Protocol Fuzzing & Hardware/Firmware Analysis
Bus sniffing, JTAG/UART, firmware extraction, and protocol fuzzing - beyond standard IT pentesting.
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Patient-Safety Driven (ISO 14971 ↔ Cybersecurity)
Cyber risk tied to patient harm, not just data - IT vendors miss this entirely.
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Threat Modeling (STRIDE / Attack Trees)
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SBOM Generation & Management
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Static Application Security Testing (SAST)
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Postmarket Vulnerability Monitoring
Continuous monitoring with our GoatWatch platform.
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ISO 13485 Quality System Alignment
Cybersecurity deliverables map cleanly into your existing ISO 13485 QMS - no parallel paperwork.
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Time to First Deliverable
Kickoff to first artifact in ~5 days, vs. 4–6 weeks at most firms.
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2
FDA Submission Support
What actually moves your submission across the finish line.
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FDA Premarket Cybersecurity Documentation
Full Section 524B submission package, eSTAR-ready.
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FDA 2026 Premarket Cybersecurity Guidance Aligned
Feb 3, 2026 guidance: SPDF, Section 524B, threat modeling, SBOM, security architecture views. Most are still catching up.
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AAMI SW96 (Medical Device Security Standard)
The new consensus standard FDA increasingly references.
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Dedicated FDA Submission Support
We've never had an FDA cyber rejection.
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Deficiency Letter & RTA Response
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EU MDR / IVDR Submissions
MDCG 2019-16 alignment for EU market submissions.
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FDA RTA / Deficiency Response Turnaround
Same-week turnaround on FDA cyber deficiency letters - included, no change orders.
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3
Business Terms
How we work, and why it removes risk for you.
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Guaranteed FDA Cybersecurity Clearance
If FDA pushes back on cyber, we keep working at no extra cost until you're cleared.
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Unlimited Retests Included
Fix findings and retest as many times as needed - no per-retest invoices.
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250+ Devices Successfully Cleared
Track record across startups to Intuitive Surgical, bioMérieux, Inogen, Natera.
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Senior Expert Assigned (No Junior Handoff)
Boutiques sometimes do this; large firms typically hand off to juniors after sales.
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Service-Disabled Veteran-Owned (SDVOSB)
Federally certified - advantageous for federal MedTech contracts.
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Full-Service (No Subcontractors)
Many vendors subcontract specialized testing; we keep it in-house.
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Fixed-Fee Pricing
Some offer fixed-fee; many bill T&M with scope creep.
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Start This Week (Not Next Quarter)
Agile team, defined processes, no onboarding queue.
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Post-Submission Support Included
We stay with you through FDA review - no extra invoices for follow-up questions.
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The honest comparison? It's not close.
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."
Numbers don't lie. Outcomes do.
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 cybersecurity package we've submitted has cleared review.
From discovery call to scoped proposal - no drawn-out sales cycles.
We don't stop testing until your device passes - at no extra cost.
Real devices. Real clearances.
A snapshot of recent engagements - from Fortune 500 medtech to pre-seed startups.
Robotic Surgical Platform
Complex Class II connected device requiring full FDA cybersecurity package under updated guidance.
Cleared on first FDA review with zero cybersecurity-related deficiencies.
Bluetooth Wearable
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.
AI-Powered Diagnostic
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.
From first call to FDA-ready in 4 steps.
Most vendors put you in a 4-to-8-week onboarding queue. We start this week.
Discovery Call
Talk directly with a senior practitioner. We learn your device, submission timeline, and risk profile. No sales reps, no qualification gauntlet.
Fixed-Fee Scope
You receive a clear scope, deliverables list, timeline, and fixed price. No hourly billing, no surprises, no scope creep.
Kickoff in Days
Our agile team starts immediately. Weekly syncs, shared workspace, and rapid feedback loops keep your regulatory team in the loop.
FDA-Ready Delivery
Threat model, SBOM, pen test report, and full submission package delivered on time. Backed by our FDA cybersecurity clearance guarantee.
Aligned to the FDA 2026 cybersecurity guidance.
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.
Security Risk Management
Threat modeling, cybersecurity risk assessment, interoperability, third-party software (SBOM + VEX), unresolved anomalies, and TPLC risk management.
Security Architecture
Global system, multi-patient harm, updateability/patchability, and security use case views, with documented security controls per Appendix 1.
Cybersecurity Testing
Security requirements, threat mitigation, vulnerability, and penetration testing - with evidence reviewers can validate.
Section 524B Compliance
Plans to monitor, identify, and address postmarket vulnerabilities; SPDF processes; and a software bill of materials (SBOM).
- FDA 2026 Premarket Cybersecurity Guidance (Feb 3, 2026)
- FD&C Act Section 524B(b)(1)(2)(3)
- Postmarket Cybersecurity Guidance
- eSTAR Submission Format
- AAMI SW96
- AAMI TIR57
- AAMI TIR97
- IEC 62304
- IEC 62443-4-1 / 4-2
- IEC 81001-5-1
- ISO 14971 (Risk)
- ISO 13485 / QMSR
- NIST SP 800-218 (SSDF)
- EU MDR 2017/745
- EU IVDR 2017/746
- MDCG 2019-16
Everything you need - premarket and postmarket.
One senior team handles every aspect of your cybersecurity, so you can focus on building life-saving devices.
SPDF Development
Complete Secure Product Development Framework aligned with FDA expectations and AAMI TIR57.
Learn moreSBOM Generation
Comprehensive Software Bill of Materials for full supply-chain transparency and lifecycle monitoring.
Learn moreThreat Modeling
Systematic identification of realistic abuse cases tied to safety and effectiveness impacts.
Learn moreeSTAR Documentation
Submission-ready cybersecurity documentation organized for fast FDA reviewer validation.
Learn moreFDA Deficiency Response
Fix cybersecurity deficiency issues fast, with experts who've done it hundreds of times.
Learn moreMedTech Compliance Bundle
FDA + SOC 2 + HIPAA + HITRUST + GDPR run in parallel on one control set - so hospital procurement and EU review don't block launch after clearance.
Learn morePostmarket Compliance
Continuous patching, monitoring, and reporting after clearance, including legacy device protection.
Learn moreWhy manufacturers switch to us.
Six commitments competitors won't put in writing.
Guaranteed FDA Clearance
If your submission is rejected for cybersecurity reasons, we fix it at no additional cost. 100% success rate to date, across hundreds of devices.
Fixed-Fee, No Surprises
We scope it, we price it, we deliver it. No hourly billing that balloons. No change orders for "unexpected complexity."
Unlimited Retests Included
Cybersecurity isn't a one-shot deal. We retest as many times as needed, within your fixed fee, until risks are mitigated.
US-Based, Dedicated Team
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.
Proprietary Tooling, Built In
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.
Personal Mission, Not a Pitch
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
The certifications that actually break into devices.
Our team holds the offensive security certifications real attackers respect - backed by hands-on U.S. government red team and military cyber operations experience.
Award-winning. Globally recognized.
Our work has been honored by leading voices in medical device cybersecurity.
MedTech Service Provider Excellence Award of the Year
Sponsored by the Malta Medicines Authority.
Medical Device Cybersecurity Services Company of the Year
Recognized for 250+ cleared FDA submissions and end-to-end medical device cybersecurity from premarket through postmarket.
Medical Device Cybersecurity Solution of the Year
Cover story profiling Blue Goat Cyber as a top industry leader.
Vet your next cybersecurity vendor.
Two practical PDFs you can use today - no email required.
10 Reasons Medical Device Cybersecurity Vendors Fail You
A practical buyer's scorecard for manufacturers - with a timeline reality check and what to demand in a fixed-fee SOW.
Vendor Evaluation Checklist
Side-by-side scorecard you can print and walk into a vendor evaluation with - covering tech, FDA, and business terms.
No email required.
Why Blue Goat Cyber
The questions that come up most when teams compare us to general cybersecurity firms.
Backed by MedTech leaders.
"The timeliness of this project exceeded my expectations - this was not my experience with other vendors. Blue Goat Cyber delivered a thorough, detailed report and complete testing faster than I anticipated, without compromising quality."
The honest comparison? It's not close.
Get a fixed-fee quote and a clear scope from a senior expert in 24 hours.