ELTON automates the cybersecurity vulnerability testing and management work the FDA expects for cyber devices, premarket and postmarket. I want to bound that claim before expanding it, because this market inflates compliance language constantly. No platform makes you FDA compliant. What a platform can do is take the most continuous, evidence-hungry slice of Section 524B obligations and run it for you.
Automation here doesn't mean a scanner on a scheduler. It means the activities the guidance actually names (penetration testing on a cadence, SBOM monitoring, CVE triage, contextual scoring) running against a model of your specific product instead of a generic checklist. The distinction matters because the FDA reviews process evidence, not tool logs.
The FDA's 2016 postmarket cybersecurity guidance asks for structured, ongoing process: monitor vulnerability sources including your SBOM and threat intelligence, score and triage findings consistently, and patch on a timeline when an issue presents uncontrolled risk. Periodic penetration testing to confirm controls still work is part of the expectation.
Most manufacturers try to run that with spreadsheets and an annual test contract, and it doesn't hold. New CVEs land against your components weekly. Every one needs a rating you can defend in an audit two years later.
The scoring piece deserves emphasis because it's where audits go first. A number without context invites the question of why you didn't fix everything above 7.0. Context is the answer: the same CVE rates differently when the vulnerable service never faces the network, and a consistent rubric is what keeps those judgments defensible across products and years.
So we automated the loop: SBOM-driven CVE monitoring, triage against the device's actual architecture, and scoring with the MDDT-recognized CVSS rubric for medical devices. The output is a living vulnerability report that updates as the product and the threat picture move, not a PDF that was stale a week after the test.
The 2025 premarket guidance builds on that base and asks for a comprehensive vulnerability management SOP inside the submission itself, plus penetration testing on both sides of clearance. Your premarket file now has to describe the postmarket machine you intend to run. That's a real shift from treating postmarket as a separate program you stand up after launch, and reviewers notice when the description is aspirational.
During development, ELTON phases penetration testing alongside SAST, DAST, fuzzing, and SBOM generation, so discovery evidence accumulates while the design is still movable. After clearance the same device model carries into continuous monitoring, CVE triage, and re-analysis whenever new intelligence lands. That model is the digital twin we build during onboarding, so postmarket triage inherits everything premarket testing learned. One system on both sides of the line, and no handoff gap between the premarket file and the postmarket process.
Compliance pressure produces patch fatigue: fix every HIGH and CRITICAL, whether or not anything can reach it. We score in architectural context instead. A LOW-severity issue that enables a HIGH-severity exploit chain can be the most valuable fix on the board, and a CRITICAL sitting behind three dead trust boundaries may deserve no patch at all.
That's what lets manufacturers apply fewer patches at root causes and still meet FDA expectations, because every decision ships with the reachability evidence behind it. Fixing less while documenting more sounds backwards until you price what a single medical device patch costs to verify and roll out.
So the honest pitch stays narrow. We meet the FDA's premarket and postmarket cybersecurity vulnerability testing and management requirements, continuously and with an evidence trail. The rest of your submission is still yours to earn. In my experience, bounded claims are the ones regulators and buyers end up trusting.
Start with one device. We build the twin from documentation your quality system already produces, run AI discovery remotely, and show you the graph: the handful to fix, and the evidence for everything else.