Your submission deadline is close. We cover all applicable FDA premarket cybersecurity requirements for your device, including documentation, testing, and submission support, with one team and a fixed-fee scope.
The short answer
The FDA Premarket Cybersecurity Package brings threat modeling, cybersecurity risk assessment, security architecture, SBOM work, security testing, labeling, and vulnerability management planning into one traceable evidence set. We scope the work to your device and pathway, distinguish Section 524B obligations from guidance recommendations, and support the cybersecurity portion of FDA review. IDE work is scoped to investigational use rather than treated as a Section 524B marketing submission.
275+ Devices Supported. Cybersecurity Work Owned In-House.
Trusted by leading MedTech companies
From a threat to submission evidence
Each security requirement connects to a threat, a control, and test evidence. Your regulatory team can follow that trail into the submission.
Fictional example. Not a client report or a prescribed FDA document format.
THREAT · TM-04
An attacker installs unauthorized firmware.
CONTROL · SEC-12
The device verifies the update signature before installation.
TEST · PT-08
A modified update is rejected; the authorized update installs.
EVIDENCE
Threat model → security requirement → test result → submission reference
The roadmap
Scope · architecture · timeline
Fixed-fee quote in writing
Data flows · trust boundaries · attack paths
Threat model & risk assessment
Components · vulnerabilities · pen testing
SBOM & test report
Traceability · labeling · plans
Ready for the FDA
Your existing quality system
Connect device cybersecurity evidence to the way your team works. We help integrate product cybersecurity procedures, records, and responsibilities into your existing quality management system (QMS).
Device-specific cybersecurity documents and the handover explaining how to maintain them belong in the premarket package. Delivering those documents is not the same as revising your organization's quality procedures.
Procedure revisions, cross-team responsibilities, evidence connections, and implementation support are agreed within your premarket engagement. They are not automatically included in every package.
Deliverables are agreed after review: a gap assessment, procedure revisions, record templates, an evidence map, and a prioritized implementation plan. Scope and pricing depend on your existing procedures and the work required.
Your quality team retains ownership and approval of the QMS. Our scope is product cybersecurity, not full QMS implementation, QMS certification, or verification and validation (V&V).
See the worked example and request a quoteThe 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.
Every fda premarket cybersecurity package 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.
Recommends risk-based cybersecurity evidence, including threat modeling, architecture views, and testing. An SPDF is encouraged, not mandatory; Section 524B separately establishes statutory duties for covered cyber devices.
Statutory duties for cyber devices on covered 510(k), De Novo, PMA, PDP, and HDE pathways: a postmarket vulnerability plan, cybersecurity and update processes, and an SBOM. IDE applications are not Section 524B submissions.
FDA's mandatory interactive submission template with structured upload slots for each cybersecurity artifact.
An end-to-end secure development approach encouraged in Section IV.A.1. Other approaches may satisfy the QMSR; Section 524B does not require a named SPDF.
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 ResponseFull 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.
Our eighteen-item delivery map organizes the work; it is not a statutory list of eighteen required documents. Section 524B sets binding obligations for cyber devices on covered pathways. The February 3, 2026 guidance recommends the supporting evidence, tailored to device risk and applicability. MDS2 is an optional procurement disclosure, not an FDA or eSTAR requirement.
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 and interoperability labeling, with optional MDS2 procurement disclosure where useful. MDS2 is not required by the FDA or eSTAR.
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.
See our IEC 62304 deliverable map and manufacturer responsibilities for where cybersecurity evidence supports software lifecycle records. The manufacturer retains software classification, general software verification and validation, QMS approval, risk acceptance, and release decisions; the map does not establish IEC 62304 conformity.
See the standalone medical device penetration-testing scope, engagement process, and starting price. The full FDA Premarket Cybersecurity Package remains a separate fixed-fee quote after scoping.
Pen-testing scope, process, and pricingReview your device scope, evidence, testing, and submission handoff before the discovery call. No email required.
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 a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed. 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 with uncontrolled risk 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 for medical device teams.
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 raises a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed, 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 | Applicable cybersecurity evidence | Applicable cybersecurity evidence | Applicable cybersecurity evidence | 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 |
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 |
|---|---|---|---|
Exclusively testing medical devices since 2022 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 with uncontrolled risk 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 a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed.
Prefer to talk now? Call (844) 939-4628. Reschedule or cancel anytime.
Straight answers from the team that will actually do the work.
