Since 2013 we have tested the devices other firms will not touch. FDA-approved, FDA-qualified, and validated to the same standards our customers ship under.
A proton therapy system is among the most dangerous devices in medicine. A multi-ton synchrotron accelerates protons to two-thirds the speed of light and steers the beam into a patient with millimeter precision. Software decides where that beam stops.
When the manufacturer needed the beam-delivery and safety-interlock stack tested, they called ELTON. We modeled the control chain, drove the real interfaces, and proved which findings could reach the beam and which could not. That is the bar we test to.
ELTON vulnerability ratings are qualified as an FDA non-clinical assessment tool. Deterministic, architecture-justified CVSS 4.0 ratings for cyber devices under FD&C Act § 524B(c), aligned to your device documentation.
Per vulnerability and per initial-access path, justified to the architecture.
Bit-for-bit identical output on identical graphs. No rater drift.
Ingest, transform, target, subgraph, score, explain. Every step traced.
Premarket submissions in the design evaluation phase.
Retrospective blinded comparison against the NVD baseline and independent third-party CVSS 4.0 raters, per vulnerability.
Repeated executions across version-controlled device documentation produced identical CVSS 4.0 vectors and scores.
A large drop in the time to evaluate hundreds of findings across SAST, DAST, SBOM, and penetration testing.
ELTON performs complex attack-surface analysis and defensibly rates vulnerabilities, often reducing a HIGH to a rating that fits the product. It is a validated solution, held to the same lifecycle rigor as a medical device.
| SRS Software Requirements Specification | v2.2 |
| SDS Software Design Specification (Core API) | v1.0 |
| SVP Design Verification Test Protocol | v1.1 |
| SVR Software Verification Report | v1.0 |
| RTM Requirements Traceability Matrix | v1.0 |
| RMF Software Risk Management File | v1.0 |
“The vulnerabilities reported to us today by third parties are AI slop. ELTON helps us automate why they don't matter, it's the only method that has held up to FDA audit.”
“We have done many FDA submissions with ELTON's data and had not a single deficiency, we test early and often with AI.”
“We use ELTON's subscription testing services and it has changed how our organization views cybersecurity testing, it's flexible, fast, and better.”
The credentials are the floor, not the pitch. Bring us your hardest device and we will show you the evidence.