Capabilities
Corrective and Preventative Actions
When a vulnerability is discovered, whether through internal testing, customer complaint, or SBOM monitoring, ELTON links the finding to affected components, automates impact analysis, and tracks remediation or justification decisions.
Overview
Traceable AI Vulnerability Decisions.
Ensure that both corrective actions and preventive measures are documented in a defensible, audit-ready format aligned with FDA requirements under 21 CFR 820.100 and 820.198.
Human opinion varies; give the same vulnerability to 10 people and you’ll get 10 different ratings. ELTON delivers one consistent score, contextualized to your product’s architecture and the security controls documented in your FDA premarket submission. The result is a vulnerability rating that is defensible, traceable, and controllable.
ELTON AI-Powered Copilot analysis is regulatory defensible through the use of the FDA-approved Rubric for Applying CVSS to Medical Devices
Attack Path Analysis
ELTON maps each product’s unique initial access points and traces potential exploit chains across components, interfaces, and trust boundaries to identify realistic attack paths and validate true system-level impact.
Subsequent Impact Analysis
ELTON automates CVSSv4 Subsequent Impact analysis by modeling trust relationships and system architecture to determine what other components may be affected if a vulnerable component is fully compromised.
New Release Simulation
ELTON evaluates whether fixing a vulnerability will reduce the severity of related issues by analyzing connected exploit paths and trust dependencies. It can alert teams to changes in system impact or residual exploitation before implementing mitigations in a new release.
Susceptibility Testing
ELTON analyzes each component’s exposed interfaces, data flows, and trust boundaries to identify which parts of the system are most susceptible to high-severity vulnerabilities, enabling targeted risk reduction and proactive security architecture improvements.
Lower Your Total Cost Of Postmarket Cybersecurity Compliance
ELTON delivers low-cost, low-risk cybersecurity through its FDA Medical Device Development Tool (MDDT) based strategy, trusted by 6 of the top 10 global manufacturers.
Advance Your Maturity
ELTON’s Cybersecurity CAPA Management
As part of your cybersecurity program, ELTON formalizes your vulnerability response operations into a fully traceable CAPA process. Whether a vulnerability is discovered internally or reported externally, ELTON supports end-to-end documentation, analysis, and resolution aligned with FDA requirements under 21 CFR 820.100 and 820.198. Our platform integrates digital twin analysis, impact modeling, and historical tracking to ensure every corrective and preventive action is defensible and audit-ready. Best of all, ELTON automates the execution, enabling aggressive and complete SOPs without the overhead of execution.
Corrective Action Planning
Create a structured CAPA plan for cybersecurity vulnerabilities with defined intake methods, triage steps, roles, and escalation paths. ELTON links each vulnerability to affected components, enabling traceable investigation, justification, or remediation all aligned with 21 CFR 820.198.
CAPA Playbooks
Develop CAPA playbooks for recurring cybersecurity events that may occur in ELTON, such as SBOM-driven CVEs, remote interface risks, or third-party software exposures. Each playbook includes root cause workflows, system-level impact tracing, and mitigation strategies mapped to your architecture and automated by ELTON.
Preventive Action Tabletop
Engage engineering, quality, and security teams in a preventive action tabletop focused on future risk avoidance. Using ELTON’s digital twin and historical findings, simulate vulnerability scenarios to reinforce secure design practices and postmarket readiness.
Use ELTON to Automate Your Compliance
Insights
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Defend Your Vulnerability Ratings to Customers and Regulators
With ELTON, level up your compliance and lower the total cost of cybersecurity ownership.