Your stage

Where are you in your FDA cybersecurity journey?

Different stages call for different next steps. Find yours below.

Exploratory

Early in development

Just starting to think about FDA cybersecurity for your device. Want to understand where you stand before committing to a submission timeline.

Start free gap analysis →

Active submission

Preparing a 510(k), De Novo, or PMA

Actively working toward FDA submission. Need a comprehensive gap analysis with prioritized remediation roadmap.

See gap reports →

24h response

RTA / Hold Letter

FDA flagged your submission

Received an RTA or FDA Hold Letter citing cybersecurity issues. Every day of delay costs revenue.

Get urgent help →

Postmarket

Post-clearance maintenance

Device is cleared and on the market. Looking for help maintaining 524B postmarket cybersecurity compliance as your device and its SBOM evolve.

Get in touch →

How it works

From zero to gap report in under 5 minutes.

5 minutes

Answer 18 questions

Tell us about your device — connectivity, development stage, SBOM status, threat modeling, testing, and more. No technical jargon required.

Instant

AI analyzes your gaps

Omakyn maps your answers across all 9 compliance areas of the FDA’s cybersecurity and AI/ML guidance and identifies every compliance gap, ranked by severity — each one tied to the specific guidance section that requires it, so you can check the finding against the source.

Actionable

Get your prioritized report

Receive a professional gap analysis report with critical gaps, remediation roadmap, and the exact next steps your team needs to take this week.

Compared

Two ways to submit. Only one is ready for screening.

The difference between a submission that clears screening and one that comes back for cybersecurity content is preparation — not paperwork.

Submitting without Omakyn

The path most submissions take.

✗Vulnerabilities discovered late — by FDA reviewers, not your team
✗Implicit cybersecurity assumptions buried in design history
✗"Hope for the best" on RTA — guidance not pre-validated
✗Reactive remediation during 90-day deficiency response
✗3-12 months of FDA back-and-forth correspondence

Submitting with Omakyn

The path to a submission that survives screening.

✓SBOM in CycloneDX format with CVE cross-references — known before filing
✓Cybersecurity formally traced through QMSR design controls (21 CFR Part 820 / ISO 13485:2016)
✓Pre-validated against FDA Section 524B requirements checklist
✓Proactive evidence packet assembled at filing time
✓Avoidable cybersecurity deficiencies found before you file, not after

What you get

Everything your regulatory team needs to move forward with confidence.

⚠

Critical gap identification

Every compliance gap ranked as Critical, High, or Medium — so you know exactly what blocks your submission.

📋

Remediation roadmap

Phased action plan with concrete timelines — what to fix this week, within 60 days, within 90 days.

📎

FDA section references

Every finding linked to the exact FDA Guidance section, so your team knows exactly where to focus.

🤖

AI/ML-specific analysis

If your device uses AI, Omakyn covers PCCP, bias analysis, GMLP, and the full FDA AI/ML SaMD framework.

📊

Compliance score

A clear percentage score and risk level — Low, Medium, or High — so you know where you stand at a glance.

📥

Shareable gap report

Review a structured report with your team, board, or investors as proof of regulatory readiness planning.

Coverage

All 9 FDA compliance areas, assessed.

Omakyn assesses your device against every area of the FDA's cybersecurity framework — and says plainly where our work ends and a testing provider starts. Every gap our analysis identifies traces back to a specific section of the regulations and standards below.

Cyber device classification Secure Product Development Framework Threat modeling & TARA SBOM review (CycloneDX / SPDX) Security architecture & design Penetration & fuzz testing — assessed, not performed Postmarket vulnerability management Labeling & eSTAR documentation AI/ML — PCCP & GMLP

Primary US regulation

FDA Cybersecurity Guidance (Feb 2026) Section 524B, FD&C Act 21 CFR Part 820 / QMSR

Quality & risk management

ISO 13485:2016 ISO 14971

Software & cybersecurity lifecycle

IEC 62304 IEC 81001-5-1 AAMI TIR57 AAMI SW96 AAMI TIR97

Cybersecurity general

ISO 27001 NIST Cybersecurity Framework NTIA Minimum Elements for SBOM

Pricing

Start free. Get your gaps. Move forward with confidence.

Start free. Get your report. Then choose how far you want to go.

Free · Start here

Gap Analyzer

✓18-question assessment

✓Compliance score & risk level

✓Top 3 critical gaps

✓No credit card · No sales call

Start free gap analysis →

Document Review

$1,500

One-time · 3 business days

You already wrote it. We check it.

✓One document: threat model, SBOM, or postmarket plan

✓Every finding cited to the guidance or template that requires it

✓Findings split by consequence: screening-hold risk vs. arguable deficiency

—We do not write or rewrite the document

Send us the document →

524B Section Review

$2,500

One-time · 5 business days

The whole section, every attachment.

✓Everything in Document Review, across the full 524B section

✓Completeness pass against what the eSTAR Cybersecurity section asks for

✓One consolidated findings memo, ordered by what stops the submission first

—We do not write or rewrite the documents

Send us the document →

Readiness Review

$4,900

One-time · 10 business days

Where you stand today

✓Prioritized gap report against FDA's premarket guidance

✓Assessment of each artifact you already have

✓The deficiencies you'd likely get if you filed as-is

✓Recommended remediation sequence

✓Recorded 15-minute video walkthrough of the findings

✓Final Delivery Report (branded PDF)

✓14 days of follow-up Q&A by email

—Does not produce documents

Get started →

Submission Package

$14,900

One-time · 4–6 weeks

Your cybersecurity documentation, written

✓STRIDE threat model, full system, assumptions documented

✓Security risk assessment based on exploitability

✓Security architecture views

✓SBOM review (CycloneDX/SPDX) + end-of-support analysis

✓Post-market vulnerability management plan

✓Cybersecurity labeling + eSTAR-formatted sections

✓Two rounds of revision

✓Recorded 15-minute video walkthrough of the findings

✓Final Delivery Report (branded PDF)

✓30 days of follow-up Q&A by email

Get started →

+ Deficiency Coverage · One-time · 4–6 weeks

$24,900 — everything in the Submission Package, plus: if FDA raises a cybersecurity deficiency on the documents we produced, we prepare the response at no additional fee, through the first Additional Information cycle. Expires 12 months after delivery.

Not yet available

What these prices do not include

Penetration testing and vulnerability testing. FDA requires testing evidence as part of your submission. We don't perform it, and our documentation doesn't replace it — you'll need a testing provider, and we'll tell you who we'd use. Also excluded: source code review, SBOM generation, implementing the remediation, full regulatory strategy, and final sign-off.

Published prices assume: up to 4 external interfaces, up to 150 SBOM components, one device or product family, no AI/ML components. Above that we quote separately — and the free gap analyzer tells you before you buy.

Everyone else asks you to book a call to find out what it costs. Here's the price, and here's exactly what's in it. Full terms in our Service Terms.

Also selling into Europe?

The EU Cyber Resilience Act excludes devices covered by the MDR and the IVDR (Article 2(2)). Health-monitoring wearables that fall outside MDR and IVDR are in scope — and in December 2025 the Commission proposed removing that exemption altogether. That proposal has not been adopted. Vulnerability reporting obligations start on 11 September 2026; full application lands in December 2027.

Check your CRA readiness — free →

Need help implementing the gaps we identified?

After your assessment, reply to your report email and let's discuss next steps.

About

We hold ourselves to the same standard of evidence we ask of you.

Founder

Martin Maciel

Founder · Vynix LLC

Twenty years installing physical access control — systems where a credential opens a door and there is a real person on the other side. That world settled decades ago what connected medical software is running into now: authenticating a control channel, replay, credential lifecycle, who may open what and with what record.

Medical device software has the opposite problem. It knows code and it knows standards, but it reasons about security as a list of component vulnerabilities. A control interface specified without authentication never shows up in an SBOM — it isn't a defective component, it's a design decision. I work on the translation between those two worlds.

I built Omakyn because the documentation side is sold as a custom consulting engagement — scoped case by case, quoted on request, priced for companies far larger than the ones that need it most. So small manufacturers skip it and find the gaps at FDA review. Here the price is published, the scope is published, and the gap analysis is 18 questions, free, with one work email and no account.

Omakyn is deliberately small. You are paying for the analysis, not for a structure — which is why the price can be published at all. If what you need is accredited penetration testing or lab work, I will say so and tell you who to use. I don't do it.

→Published prices and published scope. Nothing quoted on request

→Free 18-question gap analysis. One work email, no account, no sales call

→Every regulatory claim traced to the primary source document

→Our own security page ties every claim to a test in the code

→CompTIA Security+ SY0-701 (in progress)

Connect on LinkedIn →

Company

Vynix LLC

Legal entity

Vynix LLC

30 N Gould St, Ste N
Sheridan, WY 82801
United States

Contact

[email protected]
+1 (307) 776-3018
omakyn.com

Compliance & standards

Our methodology is based on the FDA Cybersecurity Guidance issued Feb 3, 2026 (Section 524B, FD&C Act), QMSR (21 CFR Part 820 / ISO 13485:2016), NIST Cybersecurity Framework, and ISO 27001 best practices.

Omakyn provides informational gap analysis tools and consulting guidance. Reports do not constitute legal or regulatory advice and do not guarantee FDA clearance or approval. For legal matters, consult a qualified regulatory attorney.

Where this fits

The tooling exists. It is priced for companies ten times your size.

The product security platforms built for this — MedCrypt, Finite State — sell to manufacturers with six-figure security budgets and a product security team to run them. Section 524B applies exactly the same way to a company of twelve people. That company is who this is for.

Today

Submission cybersecurity is sold as a custom consulting engagement: scoped by proposal, priced by quote, measured in months. Most small manufacturers postpone it and find the gaps when FDA asks.

Omakyn

Free gap analysis in 5 minutes. Paid tiers from $1,500 to review a document you already wrote, $4,900 for a readiness review, scaling to $14,900 for the full submission package. The only self-serve entry point into FDA 524B and the EU Cyber Resilience Act: free diagnosis, published prices, no sales call.

Who this is not for

If your device cannot connect to the internet, it is not a cyber device under 524B(c) and none of this applies. If you already run a product security team, you have this covered. The free analysis will tell you either of those instead of selling you a report.

Know your FDA gaps before the reviewer does.

FDA can hold your submission before a reviewer ever opens it.

Where are you in your FDA cybersecurity journey?

From zero to gap report in under 5 minutes.

Answer 18 questions

AI analyzes your gaps

Get your prioritized report

Two ways to submit. Only one is ready for screening.

Everything your regulatory team needs to move forward with confidence.

All 9 FDA compliance areas, assessed.

Start free. Get your gaps. Move forward with confidence.

We hold ourselves to the same standard of evidence we ask of you.

Martin Maciel

Vynix LLC

The tooling exists. It is priced for companies ten times your size.

Find your gaps before the FDA does.

Built on standards. Verified by identity.