Medical device cybersecurity for FDA submissions
Medical device cybersecurity for FDA submissions.
Penetration testing, threat modeling, SBOMs, and cybersecurity documentation for your 510(k), De Novo, or PMA submission. We agree the scope and a fixed fee. Your regulatory team reviews and submits the evidence.
Planning only. A readiness check does not establish regulatory acceptability.
Evidence aligned with the FDA's February 3, 2026 guidance and eSTAR 7.1. What medical device cybersecurity requires
- No obligation
- Expert-led from minute one
- NDA available on request
Trusted by leading MedTech teams
Your device is part of a system
Cybersecurity follows every connection.
We look beyond the device enclosure, from firmware and wireless commands to app accounts and cloud APIs.
- 01
Medical device
Firmware · stored keys · debug ports
Secure boot & signed updates
- 02
Wireless link
Bluetooth · Wi-Fi · pairing
Authentication & replay resistance
- 03
Companion app
Local data · sessions · commands
Authorization & secure storage
- 04
Cloud & portal
APIs · accounts · update delivery
Access control & tenant isolation
A cybersecurity deficiency letter puts your review on hold.
You built a device that helps patients. Your submission needs an SBOM, a threat model, test evidence, and Section 524B documentation. Your engineers are already stretched. Gaps are fixable when you find them early.
Your review goes on hold
A 510(k) Additional Information request generally puts substantive review on hold. You get a deadline to respond. Late fixes cost engineering time you planned for launch.
Gaps are often traceability gaps
Reviewers need to follow threats to controls to test evidence. A secure device can still draw questions when that trail is missing from the documents.
Postmarket issues are public
Vulnerabilities in cleared devices can lead to CISA advisories, FDA safety communications, and recalls. A maintained SBOM and disclosure process help you respond.
Our FDA submission cybersecurity process.
- 1
Book a free 30-minute call
We can sign an NDA first, then a senior engineer walks through your device and where you are in the submission.
- 2
Get a gap list and a fixed-fee quote
You see the gaps against the February 2026 FDA guidance, what you already have, and one fixed price to close the rest. No hourly billing.
- 3
Receive the agreed evidence
We build the agreed documents and testing with you. Your team submits. If the FDA raises a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed.
What we've delivered since 2022
If the FDA raises a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed. See why →
We commit to the work, not to the FDA's decision. Clearance rests with the FDA and depends on factors beyond cybersecurity.
Premarket and postmarket cybersecurity services.
Start with the work you need: a premarket package, standalone testing, a deficiency response, or postmarket support. Each proposal sets out deliverables, required inputs, exclusions, and a fixed fee.
Premarket
FDA Premarket Cybersecurity Package
One package for applicable FDA cybersecurity documentation, threat modeling, SBOMs, testing, and submission support.
- What we deliver
- Agreed documentation, threat modeling, SBOMs, testing, and submission support.
- What we need
- Existing cybersecurity documents, architecture, software inventory, and test access.
- Your responsibilities
- Your regulatory team reviews and submits. The FDA decides the outcome.
Premarket
Medical Device Penetration Testing Services
Device, firmware, app, and cloud testing for FDA submissions.
- What we deliver
- Test Plan, Test Cases, Test Report, and scoped retest evidence.
- What we need
- Device and test setup, interfaces, architecture, and threat model.
- Your responsibilities
- Standalone testing, not a full submission package. You own fixes and risk decisions.
Premarket
FDA Deficiency Response
Cybersecurity evidence and technical responses for FDA correspondence.
- What we deliver
- Gap assessment, agreed evidence updates, and a point-by-point technical response.
- What we need
- The FDA letter, current documents, and access for any needed testing.
- Your responsibilities
- You review and submit. Engineering fixes and regulatory review are separate.
Postmarket
FDA Postmarket Cybersecurity
Vulnerability monitoring, triage, and disclosure support for fielded devices.
- What we deliver
- Agreed monitoring, triage, disclosure support, and reporting records.
- What we need
- Released device configuration, SBOM, and existing vulnerability processes.
- Your responsibilities
- You own patches, release, risk acceptance, and reporting decisions.
Premarket
Medical Device Cybersecurity Consulting
Premarket-first product cybersecurity consulting, including SSDLC development, with postmarket support when scoped.
Premarket
Medical Device Threat Modeling
FDA-aligned threat models that identify risks early and speed approvals.
Premarket
AI/ML Medical Device Security
Defend AI/ML SaMD against adversarial attacks - and meet FDA's PCCP, GMLP, and 2025 AI-enabled device guidance.
Premarket
MedTech Compliance Bundle
One device security program that covers your FDA submission and the security evidence hospital procurement teams ask for, so buyer reviews don't stall your launch.
Where is your device today?
Pick the line that sounds like your team. We'll show you the services that solve it.
We need security built in before the FDA asks for it.
Getting ready to submitWe need a complete cybersecurity package for FDA premarket submissions.
Got an FDA deficiency letterThe FDA flagged our cybersecurity and the clock is ticking.
Passing hospital security reviewsHospitals won't buy until we pass their security review.
Already on the marketWe need to stay compliant and handle new vulnerabilities.
Investors and acquirersWe need to know if the target's cybersecurity will hold up with the FDA.
Not sure?Answer two quick questions and we'll point you to the right service.
Medical device cybersecurity, explained.
Medical device cybersecurity is the set of controls, documentation, and testing used to address risks to device safety and effectiveness from misuse, malicious attacks, and software supply chain vulnerabilities. The manufacturer reviews the evidence and owns risk decisions. 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 senior, US-based engineers to prepare and review cybersecurity evidence. 275+ FDA submissions supported, zero cybersecurity rejections. 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.
With peers at MedTech World
Melissa at The MedTech Conference
Melissa and Dinia at LSI Asia 2026
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 cybersecurity misconceptions we see often.
275+ FDA submissions supported, zero cybersecurity rejections. These are beliefs we encounter in our work. Each can leave gaps in your cybersecurity evidence.
“My device isn’t a cyber device.”
All three Section 524B(c) conditions must be met: sponsor-validated, installed, or authorized software; the ability to connect to the internet; and technological characteristics that could be vulnerable to cybersecurity threats. USB charging alone does not establish internet connectivity. Assess actual direct or indirect internet connections, including those through companion systems. Statutory duties and the FDA's guidance recommendations are distinct.
“My developers know cybersecurity.”
Secure coding alone does not document the device's cybersecurity evidence. Our threat-modeling scope includes data flow diagrams, trust boundaries, entry points, STRIDE analysis, attack trees, and the Threat Table. The four security architecture views are separate deliverables, not included in standalone threat modeling. A broader premarket proposal can include those views alongside the risk assessment, SBOM, and security testing. Trace threats to controls, applicable tests, and manufacturer-supplied patient-harm context.
“It’s about protecting data.”
The FDA's February 2026 final premarket guidance (Section IV) ties device cybersecurity to safety and effectiveness. Data confidentiality alone is too narrow. Your threat model should show how a compromise could harm a patient, make the device unavailable, or corrupt the data it acts on.
“We’ll add cybersecurity later.”
The FDA recommends an SPDF with traceability from architecture and threats through security requirements, test evidence, and unresolved-anomaly disposition. Late documentation gaps can require rework; the impact depends on the device and the gaps identified.
“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 Test Report documents tester independence, scope, methods, and results, Scope can include firmware, update paths, and debug interfaces when they are in the threat model. A SOC 2 report or a generic network scan does not show device-level testing.
~4 min read · 275+ FDA submissions supported, zero cybersecurity rejections
Review your gaps before scoping the work.
Use the existing tools to organize questions or explore your own assumptions. They do not establish regulatory acceptability or replace a device-specific review.
FDA cyber readiness score
Review your answers against premarket cybersecurity topics. Use the gap list to plan a discussion, not as a submission decision.
Cost-of-delay calculator
Explore a delay scenario using your own revenue and timing assumptions. Results are estimates, not predicted losses or the FDA's review timeline.
FDA readiness checklist
A 20-item self-assessment covering SPDF, SBOM, postmarket monitoring, architecture, and labeling, aligned to the FDA February 2026 premarket cybersecurity guidance.
From discovery to submission. one team, one process.
Discovery call
A senior engineer reviews your device, pathway, and timeline. NDA available.
Scope and fixed fee
A written scope, deliverables, exclusions, and one fixed fee.
Senior-led work
Penetration testing, threat modeling, SBOMs, and documentation. Every FDA-facing document is senior-reviewed.
Evidence handoff
The agreed evidence for your eSTAR, with retests included. Your team submits.
Postmarket support
Optional vulnerability monitoring, SBOM maintenance, and disclosure support.
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. These engagements were 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.
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.
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.
Want references in your device class? Ask on your discovery call , we can connect you with clients under NDA.
Title sponsor of MedTech World.
Blue Goat Cyber is title sponsor of every MedTech World 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.
QNova LifeSciences 13th Annual Partnering Forum (JPM Week)
Jan 11-14, 2027
San Francisco, CA, USA
Event details →MedTech World North America
May 5-7, 2027
West Palm Beach, FL, USA
Event details →Explore more cybersecurity questions.
Free planning tools. Results need device-specific evidence and manufacturer review; they are not regulatory decisions.
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
OSCP
Offensive Security Certified Professional
PNPT
Practical Network Penetration Tester
CBBH
Certified Bug Bounty Hunter
Security+
CompTIA Security+
PMP
Project Management Professional
- U.S. government red team experience
- Military cyber operations
- Manual business-logic testing
- Member, Medical Technology Enterprise Consortium (MTEC)
The standards behind your cybersecurity documentation.
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. Recommends an SPDF, threat modeling, SBOM, security architecture views, and security testing for cyber device submissions.
See details →Medical Device Security Risk Management
The consensus standard for medical device security risk management. Builds on the earlier AAMI TIR57 approach.
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
Full 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.
What does the FDA actually require for medical device cybersecurity?
Which devices count as 'cyber devices' under Section 524B?
Do I need a SBOM, and what format does the FDA expect?
How long does premarket cybersecurity work usually take?
What happens if the FDA issues a cybersecurity deficiency letter?
Is penetration testing required, and is automated scanning enough?
What about postmarket cybersecurity obligations?
We haven't filed our premarket submission yet. When should we engage?
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.
