Platform Capabilities
FDA-Compliant Cybersecurity Testing
One Fee. One Platform. All FDA-Required Testing.
15 Years Expertise.
FDA Compliant Reports.
#1 Testing Firm.
As the industry-leading medical device penetration testing firm, ELTON wrote the very methodology needed for successful submissions.
- Industry Leading Cybersecurity Testing Firm Since 2013.
- FDA-Approved Method for Rating Testing Vulnerability
- CVSSv4 Scoring Compliant with FDA 2027 Requirements
- FDA-Required Vulnerability Chaining Analysis
#1 Testing Firm
Trusted by 100s of startups and 6 of the top 10 manufacturers. ELTON is exclusively focused on medical device.
1000+ FDA-Approved Pentests
Hundreds of new medical devices have achieved FDA clearance using ELTON, with thousands continuously tested annually.
Validated Testing
Pre-validated for use inside a manufacturer’s ISO 13485-compliant QMS as a software tool for cybersecurity.
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1% of Vulnerabilities Actually Matter
Focus on the Vulnerabilities That Impact Regulatory Risk
ELTON was Trusted to test the world’s largest and most dangerous medical device.
Traceable and Defensible
ELTON provides full traceability and completeness across vulnerability testing by anchoring both test cases and findings to a specific product architecture, release, and execution context through its digital twin. Every vulnerability is traceable from source through testing, analysis, decision, and disposition, including clear justification for fix or no fix decisions aligned to regulatory expectations.
Penetration testing results, SBOM derived issues, and verification test cases are evaluated against actual attack paths, security controls, and trust boundaries rather than generic assumptions. This ensures testing coverage is demonstrable, no vulnerabilities are overlooked or duplicated across releases, and every decision is supported by evidence.
The result is a complete, auditable cybersecurity record that satisfies completeness expectations while avoiding unnecessary remediation over the product lifecycle.
Application Testing
Identify application vulnerabilities through penetration testing, SAST, or DAST scanning — web or local — across all use cases, work flows, and roles, identifying and stacking vulnerabilities to determine how impactful the threat is.
Platform Testing
Identify weaknesses across all platforms Windows, Linux, RTOS, embedded, infrastructure, and cloud by analyzing configurations and services within each topology, ensuring complete visibility into platform-level vulnerabilities across the entire system.
Network Testing
Identify vulnerabilities in all internal and external dataflows wired or wireless, end-to-end, ingress/egress network communications and services, including physical and application communication layers and payloads.
Hardware Testing
Enumerate vulnerabilities in hardware supporting an embedded device or physical component, such as physical interfaces, board-level memory chips and processors, debugging pins, and firmware.
Predictable Fees with ELTON ONE
ELTON ONE is one package that includes all vulnerability compliance for a single product, covering both premarket and postmarket needs in one streamlined package. All FDA required forms of vulnerability identification, SBOM generation, CVE monitoring, and FDA-aligned reporting, ensuring full coverage from development to deployment.
Actively in development and want to avoid late-stage vulnerabilities?
ELTON ONE platform subscriptions are 60% less than a single FDA-required pentest procured through a consulting firm.
Advisories
Leading Medical Device Vulnerability Researchers
Our cybersecurity researchers have identified and disclosed multiple zero-day Common Vulnerabilities and Exposures (CVEs) in networks, devices, and related software.
Verizon MiFi Invalidated CSRF Token for File Uploads
Impact: High
HtmlImport Unauthenticated Remote Code Execution
Impact: High
We are the Experts
Globally Compliant Testing
ELTON consolidates multiple vulnerability sources into a unified report, where each finding is evaluated in the context of others, meeting global expectations for vulnerability testing and assessment. View more Insights
Meet FDA Vulnerability Testing Requirements
Choose ELTON for full lifecycle vulnerability identification coverage of a single product or scale vulnerability management across your entire portfolio.