Medical device cybersecurity experts for FDA compliance
Accelerate FDA Clearance. No Cyber Gaps Left Open.
Penetration testing, SBOMs, threat modeling and eSTAR-ready documentation for 510(k), De Novo and PMA submissions, aligned with the FDA's 2026 guidance. What medical device cybersecurity requires
- No obligation
- Expert-led from minute one
- NDA available on request
Trusted by leading MedTech teams
Proof, not promises.
If the FDA raises cybersecurity deficiencies on work we delivered, we resolve them at no additional cost to you. See why →
We commit to the work, not to the FDA's decision. Clearance rests with the FDA and depends on factors beyond cybersecurity.
Medical device cybersecurity services.
Purpose-built for FDA-regulated medical devices - from premarket submission through postmarket monitoring.
Full-Service FDA Premarket Cybersecurity
Full-service: we own 100% of SPDF, SBOMs, threat modeling, pen testing, and eSTAR documentation.
View service Most RequestedMedical Device Penetration Testing
FDA-compliant device, firmware, app, and cloud testing.
View serviceFDA Deficiency Response
Got an FDA hold or AI letter? We close cybersecurity deficiencies fast.
View service NewAI/ML Medical Device Security
Defend AI/ML SaMD against adversarial attacks - and meet FDA's PCCP, GMLP, and 2025 AI-enabled device guidance.
View serviceMedTech Compliance Bundle
One program covering FDA Clearance, SOC 2, HIPAA, HITRUST, and GDPR - run in parallel for hospital-ready and EU-ready launch.
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 serviceFDA Postmarket Cybersecurity
Continuous compliance, monitoring, and vulnerability response.
View serviceMedical device cybersecurity, explained.
Medical device cybersecurity is the set of controls, documentation, and testing that keeps a device safe and effective when exposed to real-world misuse, malicious attacks, and software supply chain risk, and satisfies the FDA reviewers who verify it. 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.
Why teams call us
Device makers bring in our FDA cybersecurity compliance experts when a submission has to hold up under review. Our senior, US-based engineers have supported 275+ medical devices, and our work follows ISO 14971, AAMI TIR57, AAMI SW96 and IEC 81001-5-1.
Meet the team, visit our About page, read founder Christian Espinosa's profile, see us in the media, or see how our FDA cybersecurity compliance experts work.
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.
A 3-6 month delay on a $30M/year device
An FDA cybersecurity deficiency letter starts a 180-day response clock. Miss it and the submission is withdrawn. On a $30M/year device, a 3-month slip is $7.5M of lost revenue, plus $50K-$250K in remediation work, plus the next review queue. We have seen teams ship a year late on a single SPDF traceability gap.
An AI letter on documentation, not technology
Most FDA cybersecurity deficiencies are not 'your device is insecure.' They are 'we cannot trace your threats to your controls to your test evidence.' Reviewers issue Major Deficiency or Refuse to Accept on missing VEX statements, threat models without ISO 14971 hazard links, and SBOMs that don't match the shipping firmware. A clean technical posture still fails if the package does not read in reviewer order.
A Class I recall and a CISA advisory with your name on it
Postmarket cybersecurity events are public. A single uncontrolled vulnerability in a cleared device can trigger a CISA ICSMA advisory, an FDA safety communication, a coordinated disclosure window, and, if patient harm is plausible, a Class I recall. The remediation cost is the small line item. The Bloomberg headline, the customer phone calls, and the IRB freezes are not.
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 supporting 275+ devices, 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.”
Section 524B(c) defines a cyber device by three conditions, all of which must be met: (1) it includes software validated, installed, or authorized by the sponsor, (2) it has the ability to connect to the internet, and (3) it contains technological characteristics that could be vulnerable to cybersecurity threats. BLE pairing, a USB charging port, or a companion app each satisfy condition 2. If your device meets all three, the full SPDF, SBOM, threat model, and pen test package is mandatory - and the FDA can refuse to accept the submission without it.
“My developers know cybersecurity.”
Reviewers don't ask if your team can write secure code. They ask for a STRIDE-based threat model traced to ISO 14971 hazards, a CycloneDX SBOM with VEX justifications for every flagged CVE, security architecture views (global system, multi-patient harm, updateability, security use cases), and independent pen test evidence documenting tester independence, scope, methods and results. We watched one team's submission get a Major Deficiency because their threat model listed mitigations without traceability to the design history file - reviewer wanted to see the chain, not the conclusion.
“It’s about protecting data.”
The FDA's February 2026 final premarket guidance (Section IV) frames cybersecurity as patient safety, device availability, and data integrity - in that order. HIPAA and data confidentiality language alone gets flagged as a scope gap. Your threat model has to show how a compromise could harm a patient, render the device unavailable, or corrupt the data it acts on. That is the lens reviewers apply.
“We’ll add cybersecurity later.”
The Secure Product Development Framework (Section 524B(b)(2)) requires unbroken traceability from architecture decisions through threat model, security requirements, test evidence, and unresolved-anomaly disposition. Reviewers can tell when the chain was assembled after design freeze: dates don't line up, threat model assumptions contradict the as-built design, and the design history file has no security entries before V&V. The result is a Major Deficiency on SPDF and a request to redo design controls - 6 to 9 months added to your timeline.
“Traditional IT cybersecurity works.”
IT pen testing assumes you can take a system offline. Medical device pen testing has to respect availability constraints - you cannot brick an infusion pump mid-test. The deliverable is a signed Letter of Attestation naming the testers, their independence, scope, and methodology, plus firmware-level testing the FDA increasingly expects (secure boot verification, OTA update path, debug interfaces). A SOC 2 report or a generic vulnerability scan rebadged for the device will be rejected.
~4 min read · grounded in 275+ devices supported
Self-serve tools, built by engineers who've supported 275+ devices.
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 math Free PDFFDA readiness checklist
A 20-item self-assessment covering SPDF, SBOM, postmarket monitoring, architecture, and labeling - aligned to the FDA February 2026 premarket cybersecurity guidance.
Download the PDFFrom discovery to clearance - one team, one process.
Discovery call
30 minutes with a senior cybersecurity expert (not a sales rep) to scope your device, regulatory path, and timeline.
Tailored scope & fixed-fee quote
A clear scope of work and a fixed-fee quote built around your engagement. No T&M surprises, no scope creep.
Senior experts execute
Pen testing, threat modeling, SBOMs, and documentation led by senior practitioners. Junior engineers contribute under that senior's direction; every FDA-facing artifact is senior-reviewed.
Reviewer-ready package
A clean, eSTAR-ready evidence package with retests included. Backed by our FDA Cybersecurity Deficiency Commitment.
Postmarket operate
Postmarket monitoring, SBOM maintenance, and coordinated disclosure, so your cleared device stays compliant with FDA's Section 524B ongoing obligations.
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, each scoped and documented for FDA review.
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.
Blue Goat Cyber is title sponsor of MedTech World and cybersecurity sponsor of every LSI summit. Our team keynotes, judges, and mentors across the US, EMEA, and APAC - because the firms shaping the next generation of medical devices are the same firms we work with every day.
LSI USA '26 Emerging MedTech Summit
Mar 16-20, 2026
Dana Point, CA, USA
Event details →MedTech World North America
May 11-13, 2026
West Palm Beach, FL, USA
Event details →2026 Innovator Summit (MedTech Innovator)
Jun 2-4, 2026
San Francisco, CA, USA
Event details →LSI Asia '26 Emerging MedTech Summit
Jun 30 - Jul 2, 2026
Singapore, Singapore
Event details →Skip the sales call. Try the free tools.
No-signup tools built by the same engineers who run the FDA submissions. Most take under 5 minutes.
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 Partner of the Year
MedTech World North America
Inaugural North America Awards, in collaboration with CS Lifesciences - recognition of our patient-safety-first approach to FDA cybersecurity submissions.
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
- Member, Medical Technology Enterprise Consortium (MTEC)
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 the 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, PMA, PDP, and HDE submissions. IDE applications sit outside the statute but are still covered by the FDA's premarket cybersecurity guidance.
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 the 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
- FDA cybersecurity deficiency commitment
Talk to a medical device cyber expert
Reply within one business day. Prefer to skip the form? Book a strategy session.
Ready to see your cybersecurity gaps before the FDA does?
A free 30-minute Discovery Session with a senior MedTech expert. Walk away with a scoping plan and clear next steps.
