What's included in Blue Goat Cyber's FDA premarket cybersecurity service?

We own 100% of your FDA cybersecurity submission. That includes a documented Secure Product Development Framework (SPDF), STRIDE/TARA threat models traced to your ISO 14971 file, a CycloneDX or SPDX SBOM with VEX statements covering every third-party and open-source component, manual penetration testing across device, cloud, mobile, and wireless interfaces, the four security architecture views FDA expects (global system, multi-patient harm, updateability, security use cases), cybersecurity labeling under Section 502(f), and every eSTAR-ready section the FDA expects under Section 524B and the February 3, 2026 final guidance. Your regulatory team drops the package straight into eSTAR with no rework.

Which FDA submission types do you support?

We support FDA cybersecurity submissions for 510(k), De Novo, and PMA, plus HDE and PDP when relevant, and IDE applications at the investigational stage. Documentation, threat modeling rigor, and test depth are tailored to the pathway and to your device architecture: a Class II 510(k) infusion pump and a Class III PMA implantable have very different reviewer expectations even though the SPDF, SBOM, and pen test deliverables are common to all three. We've supported 275+ devices across these pathways to date.

Do you handle IDE (investigational device) cybersecurity?

Yes, and we scope it as the first phase of the premarket package rather than a separate purchase. One point of accuracy that trips up a lot of teams: Section 524B(a) enumerates 510(k), De Novo, PMA, PDP, and HDE. An IDE is submitted under a different section of the FD&C Act, so the statutory cyber-device requirements do not attach. The FDA's February 3, 2026 premarket guidance is broader than the statute and does cover IDE submissions, and the content lands in the investigational plan under 21 CFR 812.25 rather than in an eSTAR cybersecurity section. We build the threat model once with production-intent identifiers, stand up the SBOM pipeline against the investigational build, and write a mid-study vulnerability plan that is actually executable at your clinical sites, so the eventual marketing submission extends that work instead of rebuilding it.

Do you handle 510(k), De Novo, and PMA differently?

Yes. The SPDF, SBOM, threat model, and pen test are required for all three, but the depth and packaging differ. 510(k) emphasizes substantial-equivalence framing of cybersecurity controls. De Novo requires you to define the special controls (cybersecurity is almost always one of them) and prove your design meets them. PMA expects the deepest evidence: full traceability across design history, manufacturing controls under 21 CFR 820, and lifecycle vulnerability management. We adjust the package, the architecture views, and the labeling content accordingly so reviewers see exactly what their pathway expects.

How long does a premarket package engagement take?

For a typical Class II connected device on a 510(k) pathway, we deliver the full FDA-ready package in 4 to 6 weeks once we have device artifacts. Simpler devices close in 2 to 3 weeks. Complex platforms, AI/ML devices under a PCCP, and Class III PMA implantables run 8 to 12 weeks because of the additional architecture views, deeper pen testing, and design-history-file integration required. We can kick off this week, no 4 to 8 week onboarding queue, and you receive a fixed-fee scope within 24 hours of your discovery call.

What happens if we submitted before engaging Blue Goat and received a deficiency letter?

This is one of our most common entry points. Our FDA Cybersecurity Deficiency Response service diagnoses the exact gap within 48 hours, mapping each finding to the relevant 524B subsection ((b)(1) postmarket, (b)(2) SPDF, (b)(3) SBOM) and the underlying guidance section. We rebuild the affected artifacts (threat model, SBOM, architecture views, pen test, labeling), retest where required, and deliver a reviewer-ready point-by-point response inside the 180-day clock so you keep your place in the FDA review queue. See our Deficiency Response service page for the full process.

How is Blue Goat Cyber different from other medical device cybersecurity vendors?

We are MedTech-only, US-based, senior-engineer-led, fixed-fee, and we back our work with a deficiency commitment that covers every submission pathway. 275+ devices supported. We don't license you a dashboard and walk away (the FDA does not accept dashboards), we don't put you in a 4 to 8 week onboarding queue, and the senior practitioner who pitches the work leads delivery. Junior engineers contribute under that senior's direction, and every FDA-facing artifact is senior-reviewed. Every artifact we deliver is the artifact a reviewer asked for, formatted the way reviewers expect.

What does an engagement cost?

Pricing is fixed-fee and scoped per submission. After a 30-minute discovery call with a senior practitioner (not a sales rep), you receive a clear scope, deliverables list, timeline, and fixed price within 24 hours, with no hourly billing, no scope creep, and no change orders for 'unexpected complexity.' Cost depends on device class, ecosystem (device-only vs cloud + mobile + wireless), submission pathway, and the maturity of your existing artifacts. We share comparable engagement ranges on the call so you can budget accurately before signing.

What deliverables do we receive?

SPDF documentation traceable from architecture decisions through test evidence, a CycloneDX/SPDX SBOM with VEX statements, a STRIDE/TARA threat model linked to your ISO 14971 risk file, the four FDA-required security architecture views, a manual penetration test report with a Letter of Attestation naming testers and methodology, cybersecurity labeling content under Section 502(f), eSTAR-ready submission sections, and ongoing access to our GoatWatch SBOM monitoring platform for postmarket vulnerability tracking. Every artifact is formatted to FDA's February 2026 guidance.

Can you align our submission to global requirements and our existing QMS?

Yes. We map the agreed cybersecurity evidence to the applicable FDA submission expectations, IMDRF N60 principles, EU MDR/IVDR expectations under MDCG 2019-16, and relevant standards such as IEC 81001-5-1 and IEC 62443-4-1. Device-specific documents and their handover support your existing quality records. Revising QMS procedures, assigning cross-team responsibilities, and putting those processes into practice are separately agreed integration work. Your quality team owns and approves the QMS, and each market's submission requirements still need to be addressed.

Who actually does the work - senior engineers or a junior team?

Senior MedTech cybersecurity engineers, throughout. The expert who scopes the engagement on your discovery call is the same person who runs the threat modeling workshops, reviews the pen test report before it leaves the building, and signs the Letter of Attestation. We deliberately keep our team small and senior; every engineer has multiple years of FDA submission experience and reads the guidance documents the way a reviewer does. Junior engineers contribute under that senior's direction, and every FDA-facing artifact is senior-reviewed. There is no offshore work and no situation where the person on your kickoff call disappears after week one.

How do you handle AI/ML-enabled devices and PCCPs in the submission?

AI/ML cybersecurity work depends on the functions and risks of the device. A PCCP is optional and relevant when seeking authorization for specified future changes, not mandatory for every AI/ML device. We coordinate with your regulatory team on GMLP-aligned documentation of training data provenance and validation, transparency labeling under the 2025 draft guidance, and adversarial robustness testing that covers evasion, poisoning, and (for LLM features) prompt injection. We extend the standard threat model with MITRE ATLAS and OWASP ML Top 10, document drift monitoring and retraining triggers, and map everything to AAMI CR34971 and the NIST AI RMF so the AI-specific evidence drops cleanly into the same SPDF package.

What do we need to provide to start the engagement?

To kick off, we need device design documentation (architecture diagrams, interface lists, software design specs), the existing ISO 14971 risk file, any prior threat modeling or pen test artifacts, your QMS procedures relevant to design controls and change management, the intended submission pathway and target filing date, and access to a technical contact who can answer architecture questions. We do not need finished firmware or a frozen design - we routinely engage during late-stage development. A mutual NDA is signed before any device-specific material is shared.

Medical Device Cybersecurity

FDA Premarket Cybersecurity Package

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

What's in an FDA premarket cybersecurity package?

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.

Fixed-fee scope
Uncontrolled-risk retests included
Cybersecurity deficiency support
eSTAR v7.1 aligned

Book a free discovery call

Free 30-minute call
Fixed-fee quote after scoping
NDA available on request

Trusted by leading MedTech companies

Reviewed by Christian Espinosa, MBA · Founder & CEO

Last reviewed

From a threat to submission evidence

A connected package, not a pile of reports.

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.

Cybersecurity evidence trace

EXAMPLE

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

From kickoff to a submission-ready file.

01
Kickoff
Scope · architecture · timeline
Fixed-fee quote in writing
02
Threat model
Data flows · trust boundaries · attack paths
Threat model & risk assessment
03
SBOM & testing
Components · vulnerabilities · pen testing
SBOM & test report
04
Submission file
Traceability · labeling · plans
Ready for the FDA

Typical order of work. Steps run in parallel where the schedule allows; the fixed-fee quote lists your exact deliverables.

Your existing quality system

Cybersecurity QMS Integration

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).

Premarket documents and handover

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.

Separately agreed integration scope

Procedure revisions, cross-team responsibilities, evidence connections, and implementation support are agreed within your premarket engagement. They are not automatically included in every package.

Review and revise procedures: Review your existing cybersecurity procedures and agree revisions for development, threat modeling, security testing, SBOM maintenance, vulnerability handling, and disclosure.
Connect evidence and decisions: Map security requirements, risks, controls, and test evidence to your existing quality records. Define owners, approval steps, supplier expectations, and triggers for cybersecurity change reviews.
Put the process into practice: Connect postmarket monitoring and incident response to the teams responsible. Walk them through the agreed procedures and a worked example, with record templates and an implementation plan.

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 quote

Attack surface

Artifacts a premarket cybersecurity package covers

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.

01Architecture views (Global, Multi-Patient Harm, Updateability)
02Threat model (STRIDE + AAMI TIR57 / SW96)
03Security risk assessment (IEC 81001-5-1 §7)
04SBOM (CycloneDX 1.5 / SPDX 2.3) + VEX
05Cybersecurity controls and traceability matrix
06Penetration test evidence + retest closure
07SPDF (Secure Product Development Framework)
08Cybersecurity labeling for users
09Postmarket cybersecurity management plan

Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.

Relevant standards

Standards FDA premarket cybersecurity package maps to

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.

Featured site-wide

FDA 2026 Guidance Featured

FDA Premarket Cybersecurity Guidance (Feb 3, 2026)

Defines the SPDF, Section 524B submission package, threat modeling, SBOM, security architecture views, and cybersecurity testing every cyber device submission must include.

Section 524B

FD&C Act Cyber Device Requirements

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).

eSTAR

Electronic Submission Template

FDA's mandatory interactive submission template with structured upload slots for each cybersecurity artifact.

SPDF

Secure Product Development Framework

End-to-end secure development lifecycle the FDA expects to see referenced and evidenced in every cyber device submission.

ANSI/AAMI SW96 Featured

Medical Device Security Risk Management

The consensus standard for medical device security risk management - asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.

ISO 14971 Featured

Medical Device Risk Management

Foundational risk management standard. Cybersecurity risk is tied directly to patient-safety risk in the 14971 file.

ISO 13485 Featured

Medical Device Quality Management System

International QMS standard for medical devices. Cybersecurity deliverables are designed to slot into your existing 13485 QMS without parallel paperwork.

Notable incidents

Public premarket cybersecurity history

Recalls, CISA ICS-MA advisories, and disclosed research that shape what reviewers ask about - and what this engagement is built to cover.

the FDA·2023-2026
Section 524B refuse-to-accept threshold
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.
Advisory
the FDA·2024-2025
PMA cybersecurity Complete Response patterns
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.

Anna Norman
VP of Product · InfoBionic.Ai

Devices Supported

FDA Deliverables Mapped

Scope Owned In-House

Deficiency Gap Analysis

What's included · 18 deliverables

Cybersecurity evidence, built as one package

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.

Required by Section 524B (2) Expected by the FDA in practice (16)

Software and components

Supports Section 524B compliance

SBOM and component support/end-of-support analysis. One of two deliverables that map one-to-one to Section 524B and cannot be omitted.

SBOM (CycloneDX/SPDX)
Component support and end-of-support

Traceability flow: each step builds on the one before it

Risk management
1
Risk management report, threat model, cybersecurity risk assessment, unresolved anomalies, and measures/metrics, the anchor artifacts every downstream deliverable traces back to.
- Risk management report
- Threat model
- Cybersecurity risk assessment
- Unresolved anomalies
- Measures and metrics
Requirements and architecture
2
Security requirements, security architecture views, and interoperability risk assessment, the design evidence reviewers grade for coverage.
- Security requirements
- Security architecture views
- Interoperability risk assessment
Testing
3
SAST plus a full penetration test package (plan, cases, report) that proves the controls the threat model called for actually hold.
- SAST
- Penetration test plan
- Penetration test cases
- Penetration test report
Labeling and optional procurement disclosure
4
Cybersecurity and interoperability labeling, with optional MDS2 procurement disclosure where useful. MDS2 is not required by the FDA or eSTAR.
- Cybersecurity labeling
- MDS2
- Interoperability labeling

Management plan

Supports Section 524B compliance

Cybersecurity management plan for postmarket vulnerability handling. The second of two deliverables that map one-to-one to Section 524B.

Cybersecurity management plan

eSTAR checks for all 18 at acceptance review.

Need penetration testing without the full package?

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 pricing

FDA premarket cybersecurity readiness checklist

Review your device scope, evidence, testing, and submission handoff before the discovery call. No email required.

Download checklist (PDF)

Industry standards & frameworks we follow

Built on the standards FDA reviewers cite by name

ISO 14971
FDA 2026 Guidance
Section 524B
AAMI SW96
AAMI TIR57
AAMI TIR97
IEC 81001-5-1
IEC 62443-4-1
IEC 62304
ISO 13485
ISO 27001
NIST 800-115
UL 2900
MDCG 2019-16

How it works

From First Call to FDA-Ready in 4 Steps

Most vendors put you in a 4-to-8-week onboarding queue. We start this week.

STEP 01
Discovery Call
30 minutes
Talk directly with a senior practitioner. We learn your device, submission timeline, and risk profile. No sales reps, no qualification gauntlet.
STEP 02
Fixed-Fee Scope
Within 24 hours
You receive a clear scope, deliverables list, timeline, and fixed price. No hourly billing, no surprises, no scope creep.
STEP 03
Kickoff in Days
Not weeks
Our agile team starts immediately. Weekly syncs, shared workspace, and rapid feedback loops keep your regulatory team in the loop.
STEP 04
FDA-Ready Delivery
Committed
Threat model, SBOM, pen test report, and full submission package delivered on schedule, formatted for the eSTAR template.

Where premarket fits

Premarket is one phase of the full device lifecycle

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.

2-7 yrs out
Concept & Design
~9 mo out
Premarket
You are here
Submission day
FDA Submission
180-day clock
Deficiency Response
After clearance
Postmarket

Need design-stage help, deficiency response, or postmarket support? See all services or book a 30-min call.

Why manufacturers switch to us

Nine Commitments Competitors Won't Put in Writing

Ask any vendor for these in their SOW. We'll send ours within 24 hours.

Our FDA Deficiency Commitment

No extra cost

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.

Fixed-Fee, No Surprises

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.

Retests Included

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.

US-Based, Dedicated Team

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.

Proprietary Tooling, Built In

MedTech-only since 2022

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.

FDA-Ready Documentation Package

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.

Personal Mission, Not a Pitch

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.

Commitment Covers All Submission Pathways

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.

SPDF Built for Traceability

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.

Want this in writing?

We'll send a fixed-fee scope tailored to your submission within 24 hours.

See if we're a fit

510(k) vs De Novo vs PMA vs IDE

What changes between submission pathways

The 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.

Compare your options

How Blue Goat Cyber Stacks Up

A transparent, side-by-side look at outsourcing to us, building it in-house, or hiring a typical vendor.

Included Partial / inconsistent Not offered

Time to start

Blue GoatThis week
In-House6+ months to hire
Typical Vendor4-8 weeks

Typical cost

Blue GoatFixed fee, scoped upfront
In-House$400K+/yr fully loaded
Typical Vendor$150-$400/hr, scope creep

Time to FDA-ready package

Blue Goat4-8 weeks
In-House6-12 months
Typical Vendor3-6 months, variable

1. Technical Capabilities

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

2. FDA Submission Support

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.

3. Business Terms

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.

Book a discovery session

30-minute call · scoped quote within 24 hours.

Customer voices

What MedTech Leaders Say About Us

"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."

Scott Odland · Solutions Architect

"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."

Anna Norman · VP of Product

"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."

Amy Lynn · Chief Compliance Officer

"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."

Tim Luddy · Quality Manager

Offensive security credentials

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

Industry recognition

Award Winning. Globally Recognized.

Our work has been honored by the leading voices in medical device cybersecurity.

2026

Medical Device Cybersecurity Solution of the Year

Medical Tech Outlook - cover story profiling Blue Goat Cyber as a top industry leader.

2025

MedTech Service Provider Excellence Award of the Year

MedTech World Malta - sponsored by the Malta Medicines Authority.

2026

Medical Device Cybersecurity Partner of the Year

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.

Free tools

Pressure-test your premarket package before you book a call.

Same logic our reviewers apply on day one of an engagement. No signup, results are yours to keep.

All free tools

4 min

eSTAR Cyber Checklist

16 artifacts reviewers look for

Open tool

2 min

FDA Cyber Readiness Quiz

7-question premarket score

Open tool

2 min

Section 524B Applicability

Cyber device - yes or no?

Open tool

4 min

SBOM Readiness

Score your SBOM + supply chain

Open tool

Talk to a senior expert

Stop Worrying About FDA Cybersecurity. We Handle It All.

Join 275+ successful medical device submissions. Book a free MedTech cybersecurity strategy session - no obligation.

Free 30-minute call
With a senior medical device cyber expert, not a sales rep.
Honest scope assessment
Specific to your 510(k), PMA, De Novo, or premarket submission.
Fixed-fee quote in 24 hours
No surprises. No hourly billing. No obligation.
NDA available on request
Optional. We can sign your NDA before the first meeting.

Our Commitment

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.

FAQ

Frequently Asked Questions

Straight answers from the team that will actually do the work.

FDA Premarket Cybersecurity Package

What's in an FDA premarket cybersecurity package?

A connected package, not a pile of reports.

From kickoff to a submission-ready file.

Kickoff

Threat model

SBOM & testing

Submission file

Cybersecurity QMS Integration

Premarket documents and handover

Separately agreed integration scope

Artifacts a premarket cybersecurity package covers

Standards FDA premarket cybersecurity package maps to

FDA Premarket Cybersecurity Guidance (Feb 3, 2026)

FD&C Act Cyber Device Requirements

Electronic Submission Template

Secure Product Development Framework

Medical Device Security Risk Management

Medical Device Risk Management

Medical Device Quality Management System

Public premarket cybersecurity history

Section 524B refuse-to-accept threshold

PMA cybersecurity Complete Response patterns

Cybersecurity evidence, built as one package

Software and components

Risk management

Requirements and architecture

Testing

Labeling and optional procurement disclosure

Management plan

Need penetration testing without the full package?

FDA premarket cybersecurity readiness checklist

Built on the standards FDA reviewers cite by name

From First Call to FDA-Ready in 4 Steps

Discovery Call

Fixed-Fee Scope

Kickoff in Days

FDA-Ready Delivery

Premarket is one phase of the full device lifecycle

Nine Commitments Competitors Won't Put in Writing

Our FDA Deficiency Commitment

Fixed-Fee, No Surprises

Retests Included

US-Based, Dedicated Team

Proprietary Tooling, Built In

FDA-Ready Documentation Package

Personal Mission, Not a Pitch

Commitment Covers All Submission Pathways

SPDF Built for Traceability

Want this in writing?

What changes between submission pathways

How Blue Goat Cyber Stacks Up

1. Technical Capabilities

2. FDA Submission Support

3. Business Terms

What MedTech Leaders Say About Us

The Certifications That Actually Break Into Devices

Award Winning. Globally Recognized.

Medical Device Cybersecurity Solution of the Year

MedTech Service Provider Excellence Award of the Year

Medical Device Cybersecurity Partner of the Year

Pressure-test your premarket package before you book a call.

eSTAR Cyber Checklist

FDA Cyber Readiness Quiz

Section 524B Applicability

SBOM Readiness

Stop Worrying About FDA Cybersecurity. We Handle It All.

Discuss your package

Frequently Asked Questions

What's included in Blue Goat Cyber's FDA premarket cybersecurity service?

Which FDA submission types do you support?

Do you handle IDE (investigational device) cybersecurity?

Do you handle 510(k), De Novo, and PMA differently?

How long does a premarket package engagement take?

Does the fixed fee cover retests if FDA raises deficiencies?

What happens if we submitted before engaging Blue Goat and received a deficiency letter?

How is Blue Goat Cyber different from other medical device cybersecurity vendors?

What does an engagement cost?

What deliverables do we receive?

Can you align our submission to global requirements and our existing QMS?