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.
The short answer
An FDA premarket cybersecurity package covers every Section 524B deliverable the eSTAR template gates on: a Secure Product Development Framework narrative, a threat model with trust boundaries, a security risk assessment traced to ISO 14971 and ANSI/AAMI SW96:2023, a machine-readable SBOM with VEX, security architecture views, penetration and vulnerability testing evidence, a postmarket vulnerability management plan with coordinated disclosure, and cybersecurity labeling. Blue Goat Cyber writes and owns all 18 artifacts for a fixed fee, across 510(k), De Novo, PMA, HDE, and IDE, and answers FDA deficiencies until they close.
275+ Devices Supported. 18 FDA Deliverables Owned In-House.
Trusted by leading MedTech companies
The Feb 3, 2026 final premarket cybersecurity guidance and Section 524B(b) define what reviewers expect in your eSTAR cybersecurity attachments. Every artifact below is in scope when we run the full premarket engagement.
Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.
Most full premarket engagements land between $65k and $150k. One fixed fee covers all 18 Section 524B artifacts, FDA deficiency responses until they close, and retests included. You get the exact number in writing within 24 hours of the scoping call, before you commit to anything.
$65k - $90k
Class II software as a medical device, mobile or web front end, cloud back end, no firmware or radio scope. Single 510(k) pathway.
$90k - $125k
Most connected hardware: embedded firmware plus a companion app and cloud back end, BLE or Wi-Fi, and an OTA update path. 510(k) or De Novo.
$125k - $150k+
Class III and PMA submissions, implantables, surgical platforms, multi-device ecosystems, AI/ML components, or parallel submissions across several products.
IDE-only and single-artifact engagements (threat model alone, SBOM alone) scope below this range. Postmarket monitoring via GoatWatch is quoted separately as an annual subscription. All figures are fixed fees, not estimates, and are confirmed in writing before work starts.
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.
Recalls, CISA ICS-MA advisories, and disclosed research that shape what reviewers ask about - and what this engagement is built to cover.
Cyber devices submitted without the §524B(b) artifacts are subject to RTA. The Feb 3, 2026 guidance reaffirmed the threshold and clarified artifact-level expectations - the most common RTA trigger remains a missing or non-traceable SPDF.
CDRH CRLs in this period consistently called out under-scoped pen tests, generic threat models, and SBOMs that omit firmware components. These are the three most common premarket cybersecurity deficiencies we see across pathways.
"Blue Goat Cyber 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. It was a truly seamless experience."
Cybersecurity content for Predetermined Change Control Plans, for AI/ML and non-AI devices.
View PCCP Cybersecurity ServicesGot an FDA hold or AI letter? We close cybersecurity deficiencies fast.
View FDA Deficiency ResponseEnd-to-end FDA premarket cybersecurity package for Software as a Medical Device - cloud, mobile, and web SaMD.
View SaMD CybersecuritySee 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.
Long-form reference reading - architecture, frameworks, and end-to-end how-tos.
Shorter posts on the specific gotchas, deficiencies, and reviewer expectations we see most.
Real engagements: device class, what FDA flagged, and exactly how we closed it.
The February 3, 2026 guidance and the eSTAR template turn Section 524B into eighteen concrete deliverables. Two map one-to-one to the statute and cannot be omitted: the SBOM and the cybersecurity management plan. eSTAR gates on all of them.
SBOM and component support/end-of-support analysis. One of two deliverables that map one-to-one to Section 524B and cannot be omitted.
Traceability flow: each step builds on the one before it
Risk management report, threat model, cybersecurity risk assessment, unresolved anomalies, and measures/metrics, the anchor artifacts every downstream deliverable traces back to.
Security requirements, security architecture views, and interoperability risk assessment, the design evidence reviewers grade for coverage.
SAST plus a full penetration test package (plan, cases, report) that proves the controls the threat model called for actually hold.
Cybersecurity labeling, MDS2, and interoperability labeling, the user-facing evidence the FDA expects alongside the technical artifacts.
Cybersecurity management plan for postmarket vulnerability handling. The second of two deliverables that map one-to-one to Section 524B.
eSTAR checks for all 18 at acceptance review.
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 schedule, formatted for the eSTAR template.
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 the FDA raises cybersecurity deficiencies after our submission, we help you resolve them at no extra cost. No cybersecurity-related rejections to date across 275+ devices. Clearance is always the FDA's decision.
Elsewhere: Deficiency rework billed as a new project.
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. Retests are included in your fixed fee until every finding is closed.
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 the 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' commitments.
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 fitThe artifact list barely moves between pathways. What moves is how deeply each artifact is documented, how much testing evidence reviewers expect, and how long the clock runs. Use this to sanity-check the scope a vendor quotes you.
| Dimension | 510(k) | De Novo | PMA | IDE |
|---|---|---|---|---|
| Cyber artifacts required | All 18 | All 18 | All 18 | Scaled to the trial |
| Documentation depth | Moderate. Predicate comparison anchors scope. | High. No predicate, so controls must be justified from first principles. | Highest. Full design-history-level traceability. | Focused on patient safety during the study. |
| Penetration testing expected | Yes, independent report with plan, cases, and findings. | Yes, plus rationale tying tests to novel risk. | Yes, often with re-test after design changes. | Yes for connected devices, narrower scope. |
| Threat model scrutiny | Trust boundaries and STRIDE coverage. | Same, plus special-controls justification. | Same, plus multi-patient harm and manufacturing scope. | Same, scoped to investigational use. |
| SBOM and support dates | Machine-readable, with end-of-support dates. | Same. | Same, plus change control across modules. | Same. |
| Review clock | 90 FDA days, 180-day deficiency response window. | 150 FDA days. | 180 FDA days, panel possible. | 30 days to study start. |
| Postmarket plan weight | Required. | Required, ties into special controls. | Required, plus annual report updates. | Required for the study period. |
| Typical cyber timeline | 6-10 weeks | 10-14 weeks | 12-16+ weeks | 3-6 weeks |
| Typical fixed fee | $65k - $125k | $90k - $140k | $125k - $150k+ | Below range, scoped separately |
Timelines are cybersecurity workstream durations, not total review time. Fees are fixed and confirmed in writing before work starts.
A 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.
| Capability | Blue Goat Cyber | In-House / DIY | Typical Vendor |
|---|---|---|---|
12+ years exclusively testing medical devices Refined, MedTech-specific process - not a generic pentest checklist retrofitted for healthcare. | |||
Medical protocol testing (DICOM, HL7/FHIR, MedRadio, BLE Medical) Specialized protocols with their own attack surface. Most vendors lack the tooling or expertise. | |||
Penetration testing (device + cloud/mobile) Most competitors test only the device, not the full ecosystem. | |||
Wireless / Bluetooth / RF security testing Critical for connected devices, often limited or scoped out. | |||
Threat modeling (STRIDE / attack trees) | |||
SBOM generation & management (GoatWatch) | |||
Postmarket vulnerability monitoring Continuous monitoring with our GoatWatch platform. | |||
IEC 62443 / IEC 81001-5-1 alignment |
What actually moves your submission across the finish line.
| Capability | Blue Goat Cyber | In-House / DIY | Typical Vendor |
|---|---|---|---|
FDA premarket cybersecurity documentation Full Section 524B submission package, eSTAR ready. | |||
FDA 2026 Premarket Cybersecurity Guidance aligned SPDF, Section 524B, threat modeling, SBOM, security architecture views. Most are still catching up. | |||
AAMI SW96 (Medical Device Security Standard) The new consensus standard FDA increasingly references. | |||
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. | |||
Dedicated FDA submission support We've never had an FDA cyber rejection. | |||
Deficiency letter & RTA response | |||
Post-market Section 524B compliance path Continuous SBOM monitoring, vulnerability triage, and patch guidance after clearance. | |||
EU MDR / IVDR submissions MDCG 2019-16 alignment for EU market submissions. |
How we work, and why it removes risk for you.
| Capability | Blue Goat Cyber | In-House / DIY | Typical Vendor |
|---|---|---|---|
Committed to FDA cybersecurity clearance If the FDA pushes back on cyber, we keep working at no extra cost until the deficiency is resolved. | |||
Retests included Retests until every finding is closed, with no per-retest invoices. | |||
275+ devices supported successfully cleared Track record across startups to Intuitive Surgical, bioMérieux, Inogen, Natera. | |||
Senior expert leads your engagement | |||
Service-Disabled Veteran-Owned (SDVOSB) Federally certified, advantageous for federal MedTech contracts. | |||
Fixed fee pricing | |||
Start this week (not next quarter) Hiring a qualified MedTech security engineer typically takes 6+ months. |
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.
MedTech World North America 2026 Awards (in collaboration with CS Lifesciences) - recognition of our patient-safety-first approach to FDA cybersecurity submissions and global medical device security partnerships.
Same logic our reviewers apply on day one of an engagement. No signup, results are yours to keep.
Join 275+ 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 the 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.
Straight answers from the team that will actually do the work.
