Medical Device Cybersecurity
FDA-Compliant Vulnerability Management and Testing
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Less Than 1 Percent of Vulnerabilities Meaningfully Impact a Product
Medical Device Cybersecurity
FDA-Compliant Vulnerability Management and Testing
Request a Platform Walkthrough
Less Than 1 Percent of Vulnerabilities Meaningfully Impact a Product
Over 1,000 FDA 510k and PMA submissions
Trusted by 6 of the World’s Top 10 Manufacturers.
Streamline Approval with ELTON’s FDA-Approved Cybersecurity Methodology
Globally Trusted
Trusted by 6 of the world’s top 10 medical device manufacturers and referenced in over 1000 FDA 510K/PMA submissions.
FDA Approved
Backed by an FDA-approved Medical Device Development Tool (MDDT) for defensible vulnerability results.
ISO 13485 Validated
Pre-validated for use inside a manufacturer’s ISO 13485-compliant QMS as a software tool for cybersecurity.
New Vulnerabilities in 2026
%
Must be Triaged
%
Require Remediation
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ELTON Identifies Vulnerabilities That Matter
Support vulnerability decisions with a traceable, FDA-approved solution.
Efficient Postmarket Monitoring
Automate vulnerability identification and triage with advanced exploitability analysis, reducing patch volume while lowering cost and compliance burden across every product release.
Your Product Security Copilot
ELTON is a medical device cybersecurity platform that ties vulnerability testing, SBOM analysis, threat modeling, and ongoing monitoring directly back to product architecture and design controls, producing defensible, product adjusted risk ratings aligned to global regulatory expectations. With a fully transparent, FDA-Approved Methodology ELTON transforms complex vulnerability results into clear, actionable insight, helping teams prioritize what truly matters and maintain compliance across the product portfolio.
Regulatory Troubles
Avoid Audit Findings
Meet rigorous regulatory Vulnerability Metrics across your entire product portfolio and generate defensible evidence of testing and remediation, without spreadsheets.
Traceability.
Completeness.
FDA Defensibility.
ELTON utilized an FDA-Approved Medical Device Development Tool (MDDT) designed to support cybersecurity vulnerability management across the medical device lifecycle. With end-to-end traceability from system architecture and components through vulnerability identification, triage, and remediation, ELTON enables consistent, repeatable, and regulator-ready outputs aligned with FDA expectations.
AI-Powered Intelligence
ELTON is powered by insights from over a decade of medical device testing expertise and 1000+ FDA-approved submissions. View FDA Cybersecurity Guidance
Next-Gen Products Require Next-Gen Solutions.
With ELTON, level up your compliance and lower the total cost of cybersecurity.