510(k) Cybersecurity

510(k) Cybersecurity Evidence Package

Scoped SPDF records, SBOM work, threat modeling, architecture, testing, and labeling for your 510(k). Your regulatory team reviews and assembles the submission. Individual deliverables or the broader package. 275+ FDA submissions supported, zero cybersecurity rejections.

510(k) cybersecurity submission services aligned to the FDA February 2026 final premarket cybersecurity guidance.

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Fixed fee after scoping
Uncontrolled-risk retests included
Deficiency responses covered

275+ FDA submissions supported, zero cybersecurity rejections.

Discuss the evidence you already have, device access, and filing date. We return a fixed-fee quote within 24 hours of the scoping call; delivery dates are agreed separately.

Last updated October 26, 2026

Free 30-min discovery call

Pick a time, talk to a senior expert

Discuss your architecture, available evidence, and target dates with a senior medical device cybersecurity engineer. Agree the offering, deliverables, and manufacturer inputs before work starts. Mutual NDA signed before the call.

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Mutual NDA signed before the call. No pitch, a senior engineer will tell you straight if you don't need us.

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Included in your agreed scope

Cybersecurity evidence mapped to eSTAR
Applicable Section 524B evidence + traceability
SBOM work + vulnerability assessments
STRIDE threat model + risk assessment
Penetration test report (device, cloud, wireless)
Cybersecurity labeling + customer security guide

Trusted by medical device teams worldwide

Lifecycle scope

What's in your 510(k) cybersecurity package

The proposal identifies included deliverables, exclusions, manufacturer inputs, and review responsibilities for this engagement.

FDA 2026 Final Guidance aligned

Records are aligned to the FDA February 3, 2026 guidance. Applicable Section 524B duties are kept separate from guidance recommendations.

eSTAR evidence mapping

Agreed documents use evidence references mapped to applicable eSTAR fields. Your regulatory team checks and assembles the files.

SBOM with VEX

SPDX is the default; CycloneDX can be agreed. Available source, build, and binary evidence are reconciled. Vulnerability assessments use device evidence; VEX is optional manufacturer-reviewed communication.

STRIDE threat model

Threat model and risk assessment connect threats, controls, test evidence, and patient-harm context. Security architecture views are separate documentation scaled to the device.

Pen test sized for 510(k)

The proposal identifies device versions and included interfaces. The Test Plan, Test Cases, and Test Report document checks, findings, limitations, and retests.

Retests included

Retests for findings with uncontrolled risk are included within the agreed device version and scope. Your engineers implement fixes; your team owns risk acceptance.

Illustrative security checks

The 510(k) cybersecurity findings we see most often

Use these evidence review areas to discuss scope. They are not findings about your device or predictions of regulatory action.

SBOM missing NTIA minimum elements

Check supplier, version, identifiers, relationships, and known unknowns against available evidence. Record gaps rather than infer missing data.

Threat model not traceable to mitigations

STRIDE entries exist but no mapping to security controls, test evidence, or residual risk. Reviewer asks for the full SW96 / TIR57 traceability matrix.

Pen test scope too narrow

Only the device firmware was tested; cloud, mobile companion, and wireless interfaces were skipped. Reviewer requires the full attack surface.

No Section 524B(b)(1) postmarket plan

Premarket package missing a monitoring + coordinated vulnerability disclosure plan. Required for every cyber device since March 2023.

Cybersecurity labeling missing

No customer security guide, no SBOM disclosure, no end-of-support communication. Reviewer cites missing transparency under 524B(b)(2).

Architecture views incomplete

Global, multi-patient harm, and updateability views missing or inconsistent with the threat model. Reviewer cannot evaluate reasonable assurance.

Premarket to submission

Your 510(k) cybersecurity timeline

A sequence of work, not a fixed calendar. Dates depend on scope, evidence, device access, engineering fixes, retests, and manufacturer review. Each engagement includes only the deliverables agreed in its proposal.

Step 1 of 6: Premarket planning

Define the device and scope

Start with the clinical use and the patient harm a security failure could cause. Agree the device configuration, evidence gaps, and work to be performed.

Deliverables

Cybersecurity scope and device/interface inventory
Section 524B applicability rationale
Evidence gap list, document owners, and agreed delivery milestones

Your team's inputs

Your team supplies intended use, architecture, software versions, existing records, available device access, and the target filing date.

Review and handoff

The manufacturer confirms the system boundary and included versions. Statutory duties and guidance recommendations are assessed separately.

All phase deliverables

1. Define the device and scope
- Cybersecurity scope and device/interface inventory
- Section 524B applicability rationale
- Evidence gap list, document owners, and agreed delivery milestones
2. Model threats and security controls
- Threat model and cybersecurity risk assessment
- Global system, multi-patient harm, updateability/patchability, and security use case architecture views
- Security requirements, control coverage, and initial traceability matrix
3. Build the software evidence
- Machine-readable SBOM for the identified configuration
- Component vulnerability assessment and support/end-of-support records
- SAST and software composition analysis results with human-reviewed dispositions, where scoped
4. Test, remediate, and retest
- Security Test Plan and Test Cases linked to threats and controls
- Penetration Test Report with configuration, scope, methods, actual duration, findings, limitations, and tester independence/expertise
- Remediation tracking, retest records, and updated risk and unresolved-anomaly assessments
5. Prepare lifecycle documents
- Cybersecurity labeling and user security instructions
- Postmarket cybersecurity management plan covering monitoring, vulnerability intake, coordinated disclosure, updates, and communications
- Cybersecurity metrics and limitations, with planned monitoring separate from observed results
6. Review and assemble for eSTAR
- Security risk management report and final traceability matrix
- eSTAR cybersecurity attachment index with document titles, revisions, and section/page references
- Recorded evidence gaps, applicability rationales, and manufacturer review decisions

Already have part of the evidence?

Standalone penetration testing covers the agreed test evidence. The FDA Premarket Cybersecurity Package adds the agreed documentation work. Existing records are reviewed before deciding what to produce.

FDA Premarket Cybersecurity Package

Check the evidence, document by document

eSTAR 7.1 Cybersecurity Documentation and Evidence Map

Based on the February 3, 2026 FDA premarket cybersecurity guidance and the FDA eSTAR Program. Guidance recommendations are distinct from Section 524B statutory duties.

"Blue Goat Cyber takes the burden off our engineers and makes FDA cybersecurity requirements easy to understand. Their expertise and smooth process mean we can focus on our product, not the paperwork. The organized documentation, perfectly formatted for eSTAR, saves us countless hours."

Amy Lynn, Chief Compliance Officer, Medivis

Blue Goat Cyber vs. the alternatives

What you actually get versus a generic 510(k) shop or assembling the cyber attachment in-house.

Cybersecurity-specific 510(k) experience

Blue Goat: Dedicated cyber team, not regulatory generalists
Generic 510(k) shop: Regulatory writers without cyber depth
In-house: Engineering owns it on top of dev work

eSTAR-attachable deliverables

Blue Goat: Formatted for the cybersecurity attachment
Generic 510(k) shop: Word docs that need reformatting
In-house: Built once, reformatted each time

Threat model + SBOM + VEX + pen test

Blue Goat: Agreed deliverables; VEX optional
Generic 510(k) shop: Subcontracted across vendors
In-house: Multiple owners, integration gaps

FDA submission track record

Blue Goat: 275+ FDA submissions supported, zero cybersecurity rejections.
Generic 510(k) shop: Variable, often triggers AI letters
In-house: First-submission risk

Pricing model

Blue Goat: Fixed fee, revisions included
Generic 510(k) shop: Hourly + change orders
In-house: Hidden internal cost

Capability	Blue Goat Cyber	Generic 510(k) shop	In-house
Cybersecurity-specific 510(k) experience	Dedicated cyber team, not regulatory generalists	Regulatory writers without cyber depth	Engineering owns it on top of dev work
eSTAR-attachable deliverables	Formatted for the cybersecurity attachment	Word docs that need reformatting	Built once, reformatted each time
Threat model + SBOM + VEX + pen test	Agreed deliverables; VEX optional	Subcontracted across vendors	Multiple owners, integration gaps
FDA submission track record	275+ FDA submissions supported, zero cybersecurity rejections.	Variable, often triggers AI letters	First-submission risk
Pricing model	Fixed fee, revisions included	Hourly + change orders	Hidden internal cost

Support matched to your scope

If the FDA raises a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed.

Mutual NDA before the call

We sign a mutual NDA before the initial call so you can share device details, architecture, and FDA correspondence freely.

Fixed-fee quote within 24 hours of the call

The quote identifies deliverables, assumptions, and dates. Quote turnaround is separate from the time needed to deliver the work.

Senior US engineers, fixed fee

Senior-led cybersecurity work within the agreed scope. Your team reviews the evidence and owns risk, release, and submission decisions.

Common questions

How is evidence handed over for eSTAR?

We map agreed evidence to applicable eSTAR fields and use shared identifiers across documents. Your regulatory team reviews the files, completes sponsor statements, and submits them.

How does this compare to a generic pen test shop?

Standalone testing supplies the Test Plan, Test Cases, Test Report, and retest evidence. The broader package adds agreed threat modeling, architecture, SBOM, labeling, and management-plan work. Choose based on your existing evidence.

Do you sign an NDA before the initial call?

Yes. We complete a mutual NDA before the initial 30-minute call so you can share device details, architecture, and any prior FDA correspondence freely.

What if the FDA comes back with cybersecurity deficiencies?

Fixed fee, revisions included. We stay on the file until the cybersecurity portion is closed, including any deficiency exchanges with the FDA reviewer.

How fast can you turn this around if we're up against a clock?

Dates follow scope, evidence, access, and testing review. Engineering fixes, retests, and manufacturer review have separate milestones. No universal completion window applies.

Are your engineers US-based?

Yes. Your engagement is led by a senior US-based medical device cybersecurity specialist who owns every FDA-facing deliverable. Junior engineers contribute under that senior's direction; nothing ships to the FDA without senior review. No offshoring.

Who you're talking to

Christian Espinosa, Founder & CEO

MBA, CISSP · U.S. Air Force Academy graduate · 30+ years in cybersecurity

Christian leads the senior medical device cybersecurity team behind 275+ FDA submissions supported, zero cybersecurity rejections. Author of three books including Medical Device Cybersecurity: An In-Depth Guide.

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Ready to talk to a senior expert?

30 minutes with a senior medical device cybersecurity engineer. Mutual NDA signed before the call. No pitch, we'll tell you straight if you don't need us.

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