Based on FDA Cybersecurity Guidance — Feb 3, 2026

Know your FDA gaps before the reviewer does.

Omakyn analyzes your medical device against 83 FDA cybersecurity requirements and delivers a prioritized gap report in minutes — not months.

Start free assessment → See how it works

No sales call required · No signup · Free gap analysis in under 5 minutes

$8.9B
Global medtech cybersecurity market 2026
1,250+
AI medical devices authorized by FDA
Mandatory
FDA cybersecurity compliance — current 2026 guidance
Every connected medical device sold in the US must now comply. The compliance tooling market is wide open.
Built on
FDA Guidance Feb 2026 Section 524B, FD&C Act 21 CFR Part 820 NIST Cybersecurity Framework SBOM — CycloneDX / SPDX

The problem

45% of AI medical devices approved in 2024 had no cybersecurity documentation.

The FDA's current cybersecurity guidance (Feb 2026) makes cybersecurity compliance mandatory for every connected medical device. Most teams find out about their gaps during review — when it's too late and expensive to fix.

45%
of AI devices approved in 2024 lacked cybersecurity documentation
83
individual requirements in the FDA Feb 2026 Cybersecurity Guidance
$2M+
average cost of an FDA Refuse to Accept decision for a medtech startup

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 assessment →
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. Need continuous 524B postmarket vulnerability management and SBOM updates.

Explore continuous tier →

How it works

From zero to gap report in under 5 minutes.

01
5 minutes

Answer 18 questions

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

02
Instant

AI analyzes your gaps

Omakyn maps your answers against all 83 FDA requirements from the current Feb 2026 Guidance and identifies every compliance gap, ranked by severity.

03
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. One leads to clearance.

FDA reviewers see hundreds of cybersecurity submissions per cycle. The difference between a clean first-cycle review and an 18-month deficiency loop 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 first-cycle clearance.
  • ✓SBOM in CycloneDX format with CVE cross-references — known before filing
  • ✓Cybersecurity formally traced through 21 CFR 820.30 design controls
  • ✓Pre-validated against FDA Section 524B requirements checklist
  • ✓Proactive evidence packet assembled at filing time
  • ✓Clean first-cycle review pathway — no surprises

Framework

Where does your team sit on the curve?

The 5 Levels of FDA Cybersecurity Readiness — from reactive scrambling after a deficiency letter to continuous, automated assurance built into every release. Use the model to benchmark your team and identify what it takes to advance.

1Reactive
2Documented
3Integrated
4Proactive
5Continuous
Read the full framework →

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

83 requirements across 9 critical compliance areas.

Omakyn covers every dimension of the FDA's mandatory cybersecurity framework for medical devices.

Cyber device classification Secure Product Development Framework Threat modeling & TARA Software Bill of Materials (SBOM) Security architecture & design Penetration & fuzz testing Postmarket vulnerability management Labeling & eSTAR documentation AI/ML — PCCP & GMLP

Standards & frameworks

Aligned with the standards your reviewers expect.

Our methodology maps to the regulations and standards directly referenced by the FDA Cybersecurity Guidance (Feb 2026). Every gap our analysis identifies traces back to a specific section.

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
$0
No credit card required · No sales call
Gap Assessment
✓18-question compliance assessment
✓Compliance score & risk level
✓Top 3 critical gaps identified
✓FDA Guidance Feb 2026 aligned
Start free assessment
Most popular
Starter
$1,497
One-time payment
Report + Email Analysis
✓Full gap analysis report (all gaps)
✓Prioritized remediation roadmap
✓FDA section references per gap
✓Shareable report summary for your team
✓Personalized email analysis of top 3 gaps
✓Personalized action checklist
Get started →
Assessment
$4,997
One-time payment
Deep Compliance Review
✓Everything in Starter
✓Review of existing documentation
✓SBOM gap analysis (if available)
✓Written recommendations per area
✓Detailed written analysis per area
✓30-day email follow-up support
Get started →
Continuous
Custom
Annual subscription
Postmarket Compliance Platform
✓Everything in Assessment
✓Continuous postmarket vulnerability monitoring
✓SBOM auto-updates per release
✓FDA guidance change alerts
✓Quarterly compliance reviews
✓Audit-ready documentation maintained
Contact us →
Need help implementing the gaps we identified?
After your assessment, reply to your report email and let's discuss next steps.
Contact us →

About

Built by a cybersecurity founder who saw the gap first-hand.

Founder

Martin Maciel

Founder · Vynix LLC

I founded Vynix LLC, a cybersecurity company registered in Wyoming, USA. While studying the FDA's cybersecurity guidance for medical devices, I noticed a clear pattern: medical device manufacturers were spending $50K–200K on manual compliance audits — or worse, skipping them and discovering gaps at FDA review.

I built Omakyn to automate the gap analysis process: 18 questions, instant AI-powered report mapped to all 83 FDA requirements. The same diagnosis that costs months and tens of thousands — delivered in five minutes.

→Google Cybersecurity Professional Certificate (V2)
→Fortinet Advocate Partner
→SAM.gov registered for federal procurement
→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.

Free assessment

Find your gaps before the FDA does.

A diagnostic of your medical device against 83 FDA Section 524B cybersecurity requirements. Instant AI-powered gap report, no sales call.

Start free assessment →

18 questions · Under 5 minutes · Free

83
FDA requirements mapped
5 min
Average completion time
Section 524B
FD&C Act scope
PDF
Shareable briefing for your CISO

The opportunity

Vanta did it for SOC2. Nobody has done it for FDA.

Compliance automation is a proven category — Vanta ($1.5B), Drata ($2B), Tugboat Logic. FDA cybersecurity compliance for medical devices is an unsolved, mandatory, and rapidly growing niche with no dominant player.

Today
Manual compliance audits take 6–18 months and cost $50K–$200K per engagement. Most startups skip them and discover gaps at FDA review.
Omakyn
Free gap assessment in 5 minutes. Paid tiers from $1,497 for premarket gap reports, scaling to $4,997 full compliance packages and continuous SaaS monitoring. First mover in FDA cybersecurity compliance automation.
The path
Start with FDA cybersecurity. Expand to EU MDR, ISO 13485, HIPAA. Become the compliance OS for medtech — globally.

Compliance & credentials

Built on standards. Verified by identity.

Omakyn operates as a registered US entity, fully aligned with current FDA medical device cybersecurity guidance.

Legal entity
Registered US LLC
Wyoming, USA · 2025
D-U-N-S Number
14-276-3116
Verified business identity
SAM.gov UEI
MS98ZNMUP1R7
US federal entity registered
FDA Guidance
Feb 2026 Aligned
Premarket cybersecurity — full coverage
Requirements coverage
83 of 83 mapped
All cyber device requirements covered
QMSR compliance
Fully aligned
21 CFR Part 820 / ISO 13485:2016