Based on FDA Cybersecurity Guidance — June 27, 2025

Know your FDA gaps before the reviewer does.

Elavorn 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 signup required · Free gap analysis · Results in under 5 minutes

$8.9B
Global medtech cybersecurity market 2026
1,250+
AI medical devices authorized by FDA
Mandatory
FDA cybersecurity compliance since June 2025
Every connected medical device sold in the US must now comply. The compliance tooling market is wide open.
Built on
FDA Guidance June 2025 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 June 2025 guidance made 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 June 2025 Cybersecurity Guidance
$2M+
average cost of an FDA Refuse to Accept decision for a medtech startup

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

Elavorn maps your answers against all 83 FDA requirements from the June 2025 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.

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, Elavorn 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.
📥
Downloadable PDF report
Share the report with your team, board, or investors as proof of regulatory readiness planning.

Coverage

83 requirements across 9 critical compliance areas.

Elavorn 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

Pricing

From gap analysis to full remediation.

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

Free
$0
No credit card required
Gap Assessment
✓18-question compliance assessment
✓Compliance score & risk level
✓Top 3 critical gaps identified
✓FDA Guidance June 2025 aligned
Start free assessment
Most popular
Starter
$297
One-time payment
Report + Expert Session
✓Full gap analysis report (all gaps)
✓Prioritized remediation roadmap
✓FDA section references per gap
✓PDF report — share with your team
✓60-min expert session via Zoom
✓Personalized action checklist
Get started →
Assessment
$597
One-time payment
Deep Compliance Review
✓Everything in Starter
✓Review of existing documentation
✓SBOM gap analysis (if available)
✓Written recommendations per area
✓2 expert sessions via Zoom
✓30-day email follow-up support
Get started →
Need full remediation? 🔧
Custom implementation packages available — from $2,500. We close your gaps end-to-end.
Contact us →

Free assessment

Find your gaps before the FDA does.

18 questions · Under 5 minutes · Instant report

Free · No credit card required · Results in under 5 minutes

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.
Elavorn
Automated gap analysis in 5 minutes for $97–147/report, scaling to $500/mo SaaS for continuous 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.