Achieving Complete FDA Cybersecurity Compliance with ELTON Medical device manufacturers are under increasing pressure to meet evolving FDA cybersecurity expectations. ELTON was purpose-built to help companies meet both premarket and postmarket requirements...
How ELTON Works: From Discovery to Continuous Monitoring
Summary
ELTON transforms medical device cybersecurity into a continuous, context-aware process by first building a detailed product model through either virtual analysis or a connected DeviceLink box. This model drives deeper, architecture-aware vulnerability analysis by applying a tailored security profile to each component. ELTON then integrates findings from SBOMs, penetration testing, and automated tools like SAST/DAST, and continuously re-scores vulnerabilities using enhanced CVSSv4 metrics whenever product context changes. By linking vulnerabilities, identifying enablers, and recommending minimal-effort fixes that improve overall posture, ELTON reduces over-patching and improves resilience. Its always up-to-date living reports and traceable history streamline FDA compliance and provide ongoing, audit-ready oversight.
At its core, ELTON is designed to streamline how medical device manufacturers manage cybersecurity risk across the product lifecycle. Rather than treating security as a one-time task, ELTON turns vulnerability management into a living, breathing process. It all starts with discovery—the phase where your product is digitally mapped into what we call a product model. This model includes components, interfaces, software and hardware elements, and key data flows. Discovery can be performed virtually through code and lab observations, or physically using ELTON’s connected DeviceLink box, which interfaces with the target device to generate a digital twin. This model becomes the foundation for how all vulnerability analysis is contextualized going forward.
Once the product model is created, ELTON applies a security profile. This profile includes the privileges required to interact with each component, by-design controls such as isolation or authentication, and the architecture-level characteristics that impact risk. It is this product-aware layer that makes ELTON different from generic tools. Instead of scoring vulnerabilities in isolation, ELTON understands what part of the system a vulnerability affects and how it connects to other potential weaknesses. This is critical for determining exploitability and impact in a meaningful way.
ELTON then integrates multiple vulnerability sources into a unified view. These include SBOM-based CVE feeds, penetration test results, and automated scans such as SAST and DAST. Each finding is scored using CVSSv4, which ELTON enhances by automating the more complex metrics like Attack Requirements (AT) and providing both component- and system-level impact scores. When a new vulnerability is discovered or when a control is added or removed, ELTON re-scores all relevant findings. This ensures the security posture reflects the current reality, not a snapshot from six months ago.
Unlike traditional tools that focus on individual issues, ELTON evaluates the system holistically. It automatically identifies where low-severity vulnerabilities might enable more serious ones and how fixes to those enablers can reduce overall risk. It also helps teams visualize what changes would bring the product to a desired security posture. This eliminates guesswork and helps direct engineering toward changes that matter most—often small efforts with large impact.
The final stage is continuous monitoring. ELTON automatically ingests vulnerability feeds, re-analyzes findings when anything changes, and updates living reports in real time. This eliminates the burden of repeated triage and produces audit-ready outputs for FDA compliance. With traceable history, version-aware scoring, and built-in support for coordinated vulnerability disclosure, ELTON becomes a central source of truth for every release of every product. In a regulatory environment that demands continuous oversight, ELTON is the operational system of record that makes it possible.
