Platform Capabilities
FDA-Approved Cybersecurity Testing
Trusted by 6 of the top 10 global manufacturers, ELTON performs all FDA-required Vulnerability Testing with one report, one fee, and no additional tools required. Our Experts conduct Penetration Testing and integrate it with SAST, DAST, and SBOM sources, then apply automated triage on the results.
Pentest Experts.
FDA Approved Results.
With over 600 FDA-approved testing reports, ELTON helped shape the very methodology needed for successful submissions. We perform all required testing, but don’t just run tools. Our results are tailored to your product’s unique architecture, attack surface, and security controls, saving time, reducing costs, and eliminating submission headaches.
- Industry Leading Medical Device Pentesting Firm Since 2013.
- FDA-Approved Rubric for Applying CVSS to Medical Devices
- CVSSv4 Scoring for compliance with FDA 2027 CVSS Requirements
- FDA-Required Vulnerability Chaining Analysis for accurate severity ratings
ELTON ONE annual support model is ideal for startups or large manufacturers that must maintain continuous compliance with an FDA-required Postmarket Surveillance SOP
All Testing
Multiple sources of vulnerabilities add up to more insight and better decisions, properly simulating the FDA-required penetration tester with a full-picture mindset.
Proper Ratings
Continuous collection of vulnerability data in a single location, for consistent ratings, automated metrics, and better patch decisions.
Future Proof Results
Automate complex CVSSv4 Attack Requirements through ELTON vulnerability chaining analysis. FDA requires CVSSv4 usage by 2027. Are you ready?
ELTON integrates and correlates vulnerability data from multiple sources for an FDA-Required View of Risk.
Your FDA Testing Copilot
With over 600 FDA-approved vulnerability reports behind it, ELTON brings deep regulatory experience directly into the platform. The ELTON Copilot applies that knowledge to your product at a fraction of the cost.
By combining all major vulnerability sources including penetration testing, static analysis (SAST), dynamic analysis (DAST), and SBOM-based composition analysis, with a digital twin of each release, ELTON delivers a complete, architecture-aware view of your product’s true vulnerability exposure.
The ELTON Copilot leverages this consolidated data to build a comprehensive blueprint of where each vulnerability resides within the system, how it may be accessed from known attack surfaces, and whether it can be chained to reach sensitive assets. This enables full simulation and “what-if” analysis of threat actor behavior, exposing real safety or data impact scenarios. As a result, severity ratings are adjusted based on exploitability and context, a CVE marked as “critical” may be downgraded to a low, or several minor issues combined may justify a high rating, allowing teams to focus on what truly matters.
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
Vulnerability Testing for Medical Device
ELTON consolidates multiple vulnerability sources into a unified discovery process, where each finding is evaluated in the context of others—producing an FDA-proven output aligned with current cybersecurity guidance. 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.