Accelerate FDA Clearance. Zero Rejections.
Full-service medical device cybersecurity - penetration testing, SBOMs, threat modeling, and eSTAR-ready documentation that lands 510(k), De Novo, and PMA submissions on the first pass.
- No obligation
- Expert-led from minute one
- NDA available on request
If your submission is rejected for cyber reasons, we fix it free. See why →
Trusted by leading MedTech teams
Proof, not promises.
Medical device cybersecurity, explained.
Medical device cybersecurity keeps a device safe and effective when exposed to real-world misuse, malicious activity, and software supply chain risk. It is not generic IT security.
It focuses on how the device actually operates across hospital networks, patient homes, companion apps, cloud services, and third-party software.
When cybersecurity goes wrong, the cost is real.
MedTech teams scramble to keep up with evolving FDA requirements - and the cost of a misstep is not just a delay.
Delays that cost millions
A cybersecurity deficiency letter can push your launch back 3–6 months. For a $30M/year device, that's real revenue lost.
Rejections & deficiencies
Incomplete documentation is the most common reason for FDA cybersecurity deficiency letters. One gap can unravel a strong submission.
Patient safety & reputation
Vulnerabilities in cleared devices can trigger recalls, coordinated disclosure events, and lasting reputational damage.
See it in real life
Code Blue Chart is our sponsored, sourced timeline of 86+ documented medical-device cybersecurity events - recalls, advisories, and patient-harm cases from 1985 to today.
The threats aren't hypothetical.
A public-record timeline of medical-device cybersecurity events, sponsored by Blue Goat Cyber.
86+
Documented medtech cyber events
Sourced from FDA recalls, CISA ICSMA advisories, peer-reviewed studies, and HHS OCR filings - 1985 to today.
Explore the timeline7
Events tied to patient harm
Including the NHS-attributed cyber-related death from the 2024 Synnovis attack and three cyber-driven device recalls.
See the cases5 misconceptions delaying your FDA clearance.
After 250+ submissions, these are the beliefs we see crater MedTech timelines - every one of them ends in a hold, an AI letter, or a missed launch window.
“My device isn’t a cyber device.”
“My developers know cybersecurity.”
“It’s about protecting data.”
“We’ll add cybersecurity later.”
“Traditional IT cybersecurity works.”
~4 min read · grounded in 250+ FDA submissions
Where are you in your cybersecurity journey?
Tell us your stage. We'll highlight the engagement that fits and tailor the scope from there.
Design & Architecture Consulting
Early-stage cybersecurity guidance: threat modeling, security architecture, control selection, and SBOM strategy baked in before you lock the design.
You're early in development and want to build it right the first time.
Learn moreMedical Device Penetration Testing
Full-scope, FDA-aligned penetration testing across hardware, firmware, BLE/RF, mobile apps, APIs, and cloud - manually executed and mapped to your threat model.
You need an FDA-aligned pen test covering your device's full attack surface.
Learn morePremarket Full-Service
End-to-end FDA premarket cybersecurity package: SPDF, threat model, SBOM, security architecture views, pen testing, and eSTAR-ready Section 524B documentation.
You're preparing a 510(k), De Novo, or PMA submission.
Learn moreFDA Deficiency Response
Rapid response to FDA cybersecurity deficiency letters. We diagnose what reviewers actually want, remediate gaps, and rebuild your submission package fast.
You received FDA cybersecurity feedback and need to respond on a deadline.
Learn morePostmarket Support
Ongoing vulnerability monitoring, SBOM maintenance, coordinated disclosure handling, patch validation, and reporting to keep your cleared device compliant.
Your device is on the market and you need to stay ahead of new threats.
Learn moreDesign & Architecture Consulting
Early-stage cybersecurity guidance: threat modeling, security architecture, control selection, and SBOM strategy baked in before you lock the design.
You're early in development and want to build it right the first time.
Learn moreMedical Device Penetration Testing
Full-scope, FDA-aligned penetration testing across hardware, firmware, BLE/RF, mobile apps, APIs, and cloud - manually executed and mapped to your threat model.
You need an FDA-aligned pen test covering your device's full attack surface.
Learn morePremarket Full-Service
End-to-end FDA premarket cybersecurity package: SPDF, threat model, SBOM, security architecture views, pen testing, and eSTAR-ready Section 524B documentation.
You're preparing a 510(k), De Novo, or PMA submission.
Learn moreFDA Deficiency Response
Rapid response to FDA cybersecurity deficiency letters. We diagnose what reviewers actually want, remediate gaps, and rebuild your submission package fast.
You received FDA cybersecurity feedback and need to respond on a deadline.
Learn morePostmarket Support
Ongoing vulnerability monitoring, SBOM maintenance, coordinated disclosure handling, patch validation, and reporting to keep your cleared device compliant.
Your device is on the market and you need to stay ahead of new threats.
Learn moreCustom / Hybrid Engagement
Mix and match the services you actually need: pen test plus deficiency response, SBOM only, threat model refresh, expert witness, or a fractional cyber lead. We scope it to fit.
Not sure which stage you're in? Book a free 30-minute discovery call and we'll help you scope the right engagement.
On stage with the people shaping MedTech
Title Sponsor of every MedTech World event. Cybersecurity Sponsor for LSI. Sponsor, judge, and mentor for MedTech Innovator APAC. Plus on the ground at HLTH, The MedTech Conference (AdvaMed), Verge, and more - across the US, EMEA, and APAC. We don't just write about medical device cybersecurity - we set the agenda for it.
Medical device cybersecurity services.
Purpose-built for FDA-regulated medical devices - from premarket submission through postmarket monitoring.
FDA-Compliant SBOM Services
Create, validate, and maintain SBOMs for premarket and postmarket.
View service New · High StakesAI/ML Medical Device Security
Defend AI/ML SaMD against adversarial attacks - and meet FDA's PCCP, GMLP, and 2025 AI-enabled device guidance.
View serviceFull-Service FDA Premarket Cybersecurity
Full-service: we own 100% of SPDF, SBOMs, threat modeling, pen testing, and eSTAR documentation.
View serviceFDA Deficiency Response
Got an FDA hold or AI letter? We close cybersecurity deficiencies fast.
View serviceSecure MedTech Product Design
Bake cybersecurity into your device from day one.
View serviceMedical Device Threat Modeling
FDA-aligned threat models that identify risks early and speed approvals.
View serviceMedical Device Penetration Testing
FDA-compliant device, firmware, app, and cloud testing.
View serviceFDA Postmarket Cybersecurity
Continuous compliance, monitoring, and vulnerability response.
View serviceSelf-serve tools, built by engineers who've shipped 250+ submissions.
No sales call required. Score your readiness or model what a deficiency would cost you.
FDA cyber readiness score
7 questions mapped to FDA premarket guidance. Get a score, gap list, and your fastest path to clearance.
Score my device ROI calculatorCost-of-delay calculator
Plug in your revenue and timeline. See what one FDA cybersecurity deficiency really costs your MedTech business.
Run the mathFree PDF: FDA Medical Device Cybersecurity Readiness Checklist - 20 reviewer-tested items.
From discovery to clearance - one team, one process.
Discovery
30-minute strategy session to scope your device, regulatory path, and timeline.
Plan
A tailored cybersecurity plan mapped to your submission and product roadmap.
Execute
Testing, documentation, and SBOMs - delivered as one cohesive submission package.
Submit
FDA-ready evidence reviewers expect to see - backed by our clearance guarantee.
Operate
Postmarket monitoring, vulnerability management, and ongoing compliance.
Cybersecurity by MedTech segment.
Every device class has its own attack surface and FDA reviewer expectations. Pick yours.
Neurotech / BCI
Cybersecurity for BCIs, neuromodulation, and implantable neural devices.
ExploreCardiovascular
Cybersecurity for pacemakers, ICDs, CIEDs, and cardiac monitoring.
ExploreDiabetes / CGM
Cybersecurity for CGMs, insulin pumps, and AID systems.
ExploreSurgical Robotics
Cybersecurity for robot-assisted surgery and telesurgery platforms.
ExploreImaging & AI/SaMD
Cybersecurity for SaMD, AI/ML diagnostics, and medical imaging.
ExploreDigital Therapeutics
Cybersecurity for prescription digital therapeutics and DTx apps.
ExploreWearables / RPM
Cybersecurity for clinical wearables and RPM ecosystems.
ExploreInfusion / Drug Delivery
Cybersecurity for infusion pumps and connected drug delivery.
ExploreReal wins, anonymized.
Device names and clients are confidential. Outcomes are not. Three engagements from the last 12 months - every one cleared without a re-do.
Series-B imaging AI manufacturer (US, ~60 FTEs)
Imaging & AI/SaMD
Challenge
An FDA reviewer issued a cybersecurity AI Request on a De Novo submission for an AI triage SaMD, citing an incomplete threat model, a non-conformant SBOM, and missing evidence that the model-loading pipeline had been security-tested. The team had 30 days to respond, no in-house cybersecurity lead, and an investor-board commitment to a Q3 commercial launch.
- Deficiency cleared in21 days
- Final submission outcomeDe Novo granted
- Additional reviewer rounds0
- High/critical pen-test findings closed before response100%
Cardiac remote-monitoring manufacturer (US/EU dual market)
Cardiovascular
Challenge
A connected cardiac event monitor with cellular backhaul needed a complete premarket cybersecurity package for a 510(k), with the device launching to a national hospital network at scale. The MCU firmware had been carried over from a legacy un-cleared product line, secure boot was implemented but never audited, and the cellular AT-command surface had never been fuzzed.
- 510(k) clearanceGranted on first cycle
- Cybersecurity AIs from FDA0
- High/critical findings closed pre-submission100%
- Days from submission to clearance84
Implantable neurostimulator manufacturer (Class III, life-sustaining)
Neuromodulation / Active Implantables
Challenge
A pre-PMA implantable neurostimulator with a wireless programmer, patient remote, and cloud telemetry needed a full Section 524B cybersecurity package that would survive an Advisory Panel and a multi-cycle PMA review - with patient-safety risk tolerances far tighter than a typical 510(k). The device is life-sustaining, the radio link is proprietary, and a successful attack on the firmware update path would be unrecoverable in the field.
- PMA outcomeApproved
- Cybersecurity AI rounds resolved2 of 2
- Field-replaceable cyber controls at approval100%
- Open high/critical findings at lock0
- Schedule slip caused by cyber workstream0 days
Want references in your device class? Ask on your discovery call - we can connect you with clients under NDA.
Title sponsor of MedTech World. Sponsor of every LSI summit.
Find our team across four continents in 2026 - bring your toughest FDA cybersecurity question and walk away with a real answer.
Where to find Blue Goat Cyber in 2026
Tap any bar for full event details and how Blue Goat Cyber supports it.
MedTech World North America
May 11–13, 2026
West Palm Beach, FL, USA
Event details →LSI Asia '26 Emerging Medtech Summit
Jun 30 – Jul 2, 2026
Singapore, Singapore
Event details →LSI Europe '26 Emerging Medtech Summit
Sep 28 – Oct 1, 2026
Barcelona, Spain
Event details →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."
Award-winning. Globally recognized.
Our work has been honored by the leading voices in medical device cybersecurity.
Medical Device Cybersecurity Solution of the Year
Medical Tech Outlook
Cover story profiling Blue Goat Cyber as a top industry leader.
Medical Device Cybersecurity Services Company of the Year
Healthcare Business Review
Recognized for decade-plus experience and end-to-end solutions.
MedTech Service Provider Excellence Award of the Year
MedTech World Malta · sponsored by the Malta Medicines Authority
Honored on the global MedTech stage for FDA-facing cybersecurity work.
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.
CISSP
Certified Information Systems Security Professional
CSSLP
Certified Secure Software Lifecycle Professional
OSWE
Offensive Security Web Expert
OSCP
Offensive Security Certified Professional
CRTE
Certified Red Team Expert
CRTL
Certified Red Team Lead
CARTP
Certified Azure Red Team Professional
CBBH
Certified Bug Bounty Hunter
- U.S. government red team experience
- Military cyber operations
- Manual business-logic testing
Every standard FDA reviewers expect - covered.
We speak the language so your team doesn't have to learn it from scratch. Each framework below maps to a specific deliverable in your submission package.
Not sure which apply to you?
The Standards Decoder maps each framework to your submission pathway - 510(k), De Novo, or PMA - and the artifacts FDA expects against each.
Browse the standards glossaryCore standards · We lead with these
Premarket Cybersecurity Guidance
FDA's final premarket cybersecurity guidance, issued February 3, 2026. Defines the SPDF, threat modeling, SBOM, security architecture views, and testing every cyber device submission must include.
See details →Medical Device Security Risk Management
The consensus standard for medical device security risk management. Replaces the older TIR57 approach and is what FDA reviewers increasingly expect to see referenced.
See details →Medical Device Quality Management System
The international QMS standard for medical devices. Our cybersecurity deliverables are designed to slot into your existing 13485 system without parallel paperwork.
See details →Medical Device Risk Management
Foundational risk management standard. Cybersecurity risk is tied directly to patient-safety risk in the 14971 file - a connection FDA reviewers verify explicitly.
See details →Adjacent frameworks · Referenced in our deliverables
FD&C Act Cyber Device Requirements
Statutory cybersecurity requirement for cyber devices in 510(k), De Novo, and PMA submissions.
Electronic Submission Template
Required electronic submission format. We deliver eSTAR-ready cybersecurity documentation.
Secure Product Development Framework
End-to-end secure development lifecycle aligned with FDA premarket expectations.
Principles for Medical Device Security
Earlier security risk management technical report - still referenced where SW96 has not yet been adopted.
Health Software Security Activities
International standard for security activities across the health software product lifecycle.
Medical Device Software Lifecycle
Software lifecycle requirements that intersect with secure development practices.
We also align with
FDA 2026 Premarket Guidance · ANSI/AAMI SW96 · ISO 13485 · ISO 14971 · FDA Section 524B · AAMI TIR57 · AAMI TIR97 · IEC 81001-5-1 · IEC 62443-4-1 · IEC 62304 · NIST 800-115 · ISO 27001 · UL 2900
Free resource · PDF
The MedTech Cybersecurity Standards Decoder
FDA Section 524B, AAMI SW96, ISO 14971, IEC 81001-5-1 and more - what each requires, how they connect, and what FDA expects to see. No email, no signup.
Medical device cybersecurity, answered.
The questions MedTech teams ask us most about FDA cybersecurity expectations, SBOMs, pen testing, and what regulators actually want to see.
Get in touch
Tell us about your device.
A senior MedTech cybersecurity engineer will reply within one business day with a clear next step - no sales rep, no scripted call.
- Senior engineer on the first reply
- Aligned to FDA's 2026 premarket guidance
- 100% FDA clearance guarantee
Talk to a medical device cyber expert
Reply within one business day. Prefer to skip the form? Book a strategy session.
Ready to clear FDA cybersecurity on the first pass?
A free 30-minute Discovery Session with a senior MedTech expert. Walk away with a scoping plan and clear next steps.