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...
Why Medical Device Manufacturers Are Choosing ELTON for Vulnerability Management
Summary
ELTON is a continuous vulnerability management platform purpose-built for medical device manufacturers to meet evolving FDA cybersecurity requirements. It replaces static, point-in-time reports with real-time, living vulnerability intelligence that integrates penetration testing, SBOM analysis, SAST/DAST, and public CVE feeds. By applying contextual scoring based on actual product architecture and usage, ELTON ensures accurate, defensible risk ratings. It enables portfolio-wide oversight, tracks vulnerability history across releases, and supports CVSSv4 attack requirement modeling. The result is improved compliance, fewer unnecessary patches, and smarter, system-aware remediation decisions.
Why Medical Device Manufacturers Are Choosing ELTON for Vulnerability Management
Cybersecurity for medical devices has entered a new era—one where continuous oversight is not just best practice but regulatory expectation. The FDA’s June 2025 guidance makes it clear: manufacturers must maintain a process to monitor, identify, and address vulnerabilities for all commercialized products. This includes legacy devices still in use, not just the latest release. The challenge for manufacturers is clear: how can you maintain visibility, manage risk, and meet these requirements without creating an operational bottleneck?
ELTON was purpose-built to meet this demand. Our solution offers a continuous, product-centric approach to vulnerability management, combining real-time updates, advanced risk scoring, and postmarket compliance automation. By integrating with your existing product lifecycle, ELTON gives security and regulatory teams a clear, dynamic view of device security posture—without adding extra lift to your engineering teams.
Static Reports Are Out. Living Vulnerability Intelligence Is In.
Traditional cybersecurity assessments provide a moment-in-time snapshot of vulnerabilities. These reports quickly become stale as new CVEs emerge, product configurations change, or third-party libraries evolve. ELTON replaces this outdated model with real-time, living reports that continuously reflect the current threat landscape. Our system automatically ingests public CVE feeds, re-scores vulnerabilities based on up-to-date component and system-level context, and ensures every commercial release has an active, traceable vulnerability profile.
Penetration test results, SBOM analysis, SAST/DAST outputs, and component usage insights are merged into a single view. This integrated approach eliminates siloed processes and ensures that every new vulnerability or architecture change is reflected across your entire vulnerability inventory. Teams no longer need to manually refresh reports or reprocess findings—ELTON handles that automatically and continuously.
Smarter Scoring with Product Context
Generic vulnerability scores can lead teams astray. A HIGH-severity issue in one device may be completely irrelevant in another. ELTON solves this by applying contextual analysis to every vulnerability, scoring each based on real architecture, dataflow, attack surface, and mitigations—not assumptions. We factor in how components are actually used, what privileges are required, and whether layered controls block exploitability. This means scores in ELTON are accurate, meaningful, and defensible.
With support for CVSSv4, ELTON goes further by dynamically computing the complex “Attack Requirements” metric and offering both component-level and system-level impact assessments. Our platform also analyzes chained vulnerabilities—showing when a LOW-severity flaw might elevate the impact of another issue. These capabilities help teams fix what matters most and avoid chasing false positives or unnecessary patching.
Portfolio-Wide Oversight Made Simple
Managing vulnerabilities across a portfolio of products, versions, and releases can be overwhelming without the right tooling. ELTON consolidates findings from across your entire ecosystem into a centralized system of record. You can view and triage vulnerabilities by product, release, or component—and even track like-vulnerabilities across different devices to spot systemic risks. This makes it easier to scale compliance and remediation strategies, reduce duplicated effort, and enforce consistent policy enforcement across business units.
Our “product-as-code” digital twin models every release’s architecture, interfaces, and security controls—allowing cross-comparison, visual dataflows, and easier change impact analysis. This not only saves time but equips engineering and regulatory teams with the insight they need to manage cybersecurity at scale.
Meet FDA Expectations. Minimize Effort. Maximize Impact.
The FDA now expects more than one-time testing and static documentation. Manufacturers must demonstrate a proactive, ongoing process to monitor and address vulnerabilities. ELTON delivers this out of the box. Our solution automatically re-evaluates findings as new threats are published, captures historical scoring changes, and supports full audit traceability. We provide the documentation and dashboards needed to satisfy regulatory auditors and internal stakeholders alike.
Most importantly, ELTON optimizes your remediation strategy. Instead of blindly fixing every HIGH, it highlights root causes and offers guidance on small changes that can yield significant posture improvements. This includes addressing the LOW-severity enabling vulnerabilities that quietly support higher-risk issues.
ELTON also satisfies key FDA postmarket requirements by maintaining separate, continuously updated vulnerability profiles for every commercial release. It automatically tracks and reports vulnerability density and time-to-triage metrics across all monitored products—providing clear, automated evidence of a compliant, ongoing cybersecurity process. The end result is safer devices, stronger regulatory alignment, and significantly reduced operational burden.
