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...
Automating FDA Cybersecurity Compliance with ELTON
Summary
ELTON empowers medical device manufacturers to meet FDA cybersecurity requirements from development through postmarket support by providing an end-to-end vulnerability management solution. Fully aligned with both the 2016 postmarket and 2025 premarket FDA guidance, ELTON automates critical activities like periodic penetration testing, SBOM monitoring, CVE triage, and contextual vulnerability scoring. By combining multiple discovery methods—including fuzzing, SAST/DAST, and architecture-aware analysis—ELTON delivers a continuous, product-specific security posture. Its intelligent, posture-based approach reduces unnecessary patching by identifying root causes and exploit chains, resulting in fewer fixes, lower cost, and stronger regulatory compliance.
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 efficiently, while reducing unnecessary patching through smarter, context-aware vulnerability management. By combining automated tooling, continuous monitoring, and product-specific analysis, ELTON supports the full scope of regulatory expectations—helping teams comply with the 2016 FDA postmarket guidance and the 2025 premarket requirements from the moment a device enters development through its entire lifecycle.
The FDA’s 2016 postmarket cybersecurity guidance emphasizes the need for manufacturers to implement processes for identifying, assessing, and managing vulnerabilities after a device is released. This includes monitoring vulnerability sources such as SBOMs and threat intelligence feeds, assessing risks through consistent vulnerability scoring and triage, and deploying timely patches for vulnerabilities that result in uncontrolled risk. Importantly, the guidance identifies periodic penetration testing as a required activity to verify the continued effectiveness of security controls. ELTON enables all of this through automated CVE monitoring tied to each SBOM, contextual CVSS scoring that factors in system design and usage, and living vulnerability reports that remain current as product or threat conditions change.
The 2025 FDA premarket cybersecurity guidance expands upon this by requiring manufacturers to submit a comprehensive vulnerability management plan, including standard operating procedures (SOPs) that demonstrate how postmarket vulnerabilities will be identified, assessed, and addressed. It also reinforces the need for periodic penetration testing both before and after market entry. ELTON’s ONE service package addresses these requirements in full—providing phased penetration testing, SAST/DAST, fuzzing, and SBOM generation during development, and then transitioning into continuous monitoring, CVE triage, and re-analysis throughout the device lifecycle. This results in a fully traceable and defensible vulnerability posture, ready for both submission and audit.
What makes ELTON unique is its ability to reduce patch fatigue. Most patching strategies focus on fixing everything labeled HIGH or CRITICAL, often without context. ELTON evaluates vulnerabilities holistically, analyzing architectural relationships, privilege requirements, and exploit chains. In many cases, fixing a LOW-severity vulnerability that enables a HIGH-severity issue is more impactful than addressing the HIGH directly. This posture-based approach means manufacturers can apply fewer patches, target root causes, and still meet FDA expectations—all while improving product security over time.
In an industry where patient safety, product reliability, and regulatory scrutiny are non-negotiable, ELTON provides a smarter path forward. By fully aligning with FDA cybersecurity guidance from both 2016 and 2025, and by automating the hardest parts of vulnerability management—including periodic penetration testing—ELTON gives manufacturers the tools they need to stay compliant, reduce costs, and build trust with regulators and customers alike.
