We manage 100% of your FDA cybersecurity submission - SPDF, SBOMs, threat modeling, penetration testing, and all documentation - for 510(k), De Novo, PMA, and IDE clearances.
250+ Submissions. Zero Rejections.
Trusted by leading MedTech companies
Every full-service fda premarket cybersecurity engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
Every full-service fda premarket cybersecurity engagement produces evidence aligned to the regulatory and consensus standards FDA reviewers and notified bodies expect to see - traceable, complete, and ready to drop into your ISO 13485 quality system.
Defines the SPDF, Section 524B submission package, threat modeling, SBOM, security architecture views, and cybersecurity testing every cyber device submission must include.
Statutory requirement that every cyber device 510(k), De Novo, PMA, and IDE submission include a complete cybersecurity package or face Refuse to Accept (RTA).
FDA's mandatory interactive submission template with structured upload slots for each cybersecurity artifact.
End-to-end secure development lifecycle the FDA expects to see referenced and evidenced in every cyber device submission.
The consensus standard for medical device security risk management - asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.
Foundational risk management standard. Cybersecurity risk is tied directly to patient-safety risk in the 14971 file.
International QMS standard for medical devices. Cybersecurity deliverables are designed to slot into your existing 13485 QMS without parallel paperwork.
We handle every aspect of your premarket cybersecurity submission so you can focus on building life-saving devices.
Complete Secure Product Development Framework, formatted and traceable for FDA premarket review, showing the security decisions made at every stage of development. This is the artifact reviewers open first; it has to demonstrate security was designed in, not added after.
Manually executed penetration testing across device, cloud, mobile, and wireless interfaces, plus a CycloneDX/SPDX SBOM that covers all third-party and open-source components, because that is what Section 524B requires, not just a list of first-party code.
Reviewer-ready threat models built to FDA's STRIDE and TARA expectations, with attack trees and trust boundaries that prove design-time risk consideration, the artifact reviewers look for inside the SPDF.
Documentation aligned to Section 524B, FDA eSTAR, IMDRF N60, and EU MDR, so a single submission package satisfies multiple named standards instead of being reformatted per market.
Submission-ready cybersecurity sections formatted exactly the way FDA reviewers expect, dropped directly into the eSTAR template with zero rework on your regulatory team.
End-to-end support for 510(k), De Novo, and PMA, plus EU MDR/IVDR alignment under MDCG 2019-16.
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 clearance guarantee.
We focus this page on premarket because that's likely why you're here - but we support the whole journey, from early design through post-market monitoring.
Need design-stage help, deficiency response, or postmarket support? See all services or book a 30-min call.
Ask any vendor for these in their SOW. We'll send ours within 24 hours.
If FDA raises cybersecurity deficiencies after our submission, we resolve them at no additional cost to you. 100% success rate to date, across 250+ submissions.
Elsewhere: Outcome disclaimers and 'best effort' language.
We scope it, we price it, we deliver it. No hourly billing that balloons. No change orders for 'unexpected complexity.'
Elsewhere: Hourly T&M with scope creep.
Cybersecurity isn't a one-shot deal. We retest as many times as needed, within your fixed fee, until risks are mitigated.
Elsewhere: Per-retest invoices.
Every engineer on your project is US-based and works exclusively for Blue Goat. No offshore handoffs, no shared resources.
Elsewhere: Offshore subcontractors and shared resources.
GoatWatch (our SBOM management platform) and our client collaboration portal are included, not upsold. Built from 12+ years securing medical devices.
Elsewhere: Tooling sold separately as add-ons.
We deliver eSTAR-ready cybersecurity sections, SBOMs, threat models, and test reports formatted to FDA's 2026 guidance - not raw findings dumped on your RA team.
Elsewhere: Raw findings handed off to your RA team.
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.
Elsewhere: Cybersecurity as a side practice.
510(k), De Novo, or PMA: if FDA flags a cybersecurity issue after our submission, we resolve it at no additional cost, regardless of the pathway.
Elsewhere: Pathway-limited or 'best effort' guarantees.
Every artifact in the package, threat model, SBOM, architecture views, pen test, labeling, maps to a specific FDA reviewer expectation, so there are no gaps for reviewers to question.
Elsewhere: Disconnected artifacts your RA team has to stitch together.
We'll send a fixed-fee scope tailored to your submission within 24 hours.
See if we're a fitA transparent, side-by-side look at outsourcing to us, building it in-house, or hiring a typical vendor.
Time to start
Typical cost
Time to FDA-ready package
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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Threat modeling (STRIDE / attack trees)
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SBOM generation & management (GoatWatch)
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Postmarket vulnerability monitoring
Continuous monitoring with our GoatWatch platform.
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IEC 62443 / IEC 81001-5-1 alignment
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What actually moves your submission across the finish line.
| Capability | Blue Goat Cyber | In-House / DIY | Typical Vendor |
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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
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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Pre-Submission (Q-Sub) meeting support
We help you prep cyber questions for FDA Q-Subs to de-risk the submission before it's filed.
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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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Post-market Section 524B compliance path
Continuous SBOM monitoring, vulnerability triage, and patch guidance after clearance.
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EU MDR / IVDR submissions
MDCG 2019-16 alignment for EU market submissions.
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How we work, and why it removes risk for you.
| Capability | Blue Goat Cyber | In-House / DIY | Typical Vendor |
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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)
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Service-Disabled Veteran-Owned (SDVOSB)
Federally certified, advantageous for federal MedTech contracts.
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Fixed fee pricing
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Start this week (not next quarter)
Hiring a qualified MedTech security engineer typically takes 6+ months.
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30-minute call · scoped quote within 24 hours.
"Blue Goat's niche expertise in FDA-facing cybersecurity made all the difference. Their reports were built with the FDA's expectations in mind, which gave us confidence that we were submitting exactly what reviewers want to see."
"Blue Goat helped us navigate our first end-to-end cybersecurity testing for our wearable medical device. Their communication was excellent, their timeline exceeded expectations, and their report helped us achieve FDA clearance without any additional questions."
"Blue Goat Cyber takes the burden off our engineers and makes FDA cybersecurity requirements easy to understand. The organized documentation, perfectly formatted for eSTAR, saves us countless hours."
"Blue Goat's knowledge of regulatory requirements versus cybersecurity challenges was highly valuable. Their team and competencies nicely filled our resource needs as a startup."
Our team holds the offensive security certifications real attackers respect, backed by hands-on U.S. government red team and military cyber operations experience.
Certified Information Systems Security Professional
Certified Secure Software Lifecycle Professional
Offensive Security Web Expert
Offensive Security Certified Professional
Certified Red Team Expert
Certified Red Team Lead
Certified Azure Red Team Professional
Certified Bug Bounty Hunter
Our work has been honored by the leading voices in medical device cybersecurity.
Medical Tech Outlook - cover story profiling Blue Goat Cyber as a top industry leader.
MedTech World Malta - sponsored by the Malta Medicines Authority.
Healthcare Business Review - recognized for 250+ cleared FDA submissions and end-to-end medical device cybersecurity from premarket through postmarket.
The exact deficiencies we see in 510(k), De Novo, and PMA submissions - why FDA flags them, and how to fix each one before you submit.
Straight answers from the team that will actually do the work.
Join 250+ successful medical device submissions. Book a free MedTech cybersecurity strategy session - no obligation.
With a senior medical device cyber expert, not a sales rep.
Specific to your 510(k), PMA, De Novo, or premarket submission.
No surprises. No hourly billing. No obligation.
Optional. We can sign your NDA before the first meeting.
If FDA raises cybersecurity deficiencies after our submission, we resolve them at no additional cost to you.
Prefer to talk now? Call (844) 939-4628. Reschedule or cancel anytime.
A senior medical device cybersecurity expert will reply within one business day.
Got an FDA hold or AI letter? We close cybersecurity deficiencies fast.
Learn moreEnd-to-end FDA premarket cybersecurity package for Software as a Medical Device - cloud, mobile, and web SaMD.
Learn moreContinuous compliance, monitoring, and vulnerability response.
Learn moreSee how this service applies to your specific MedTech segment.
Curated reading for teams working on fda premarket cybersecurity - grouped by format so you can jump to what you need.
