Tests one product, monitors it and keeps its report current, at one annual price.
Managed operation, platform access and TestLink hardware, in every subscription.
The full platform service, from the first test to a year of monitoring.
AI test cases mapped to your scope, executed and pentested on the real product.
Components, dataflows, interfaces and assets per release; every finding traces to a twin component.
Software and hardware materials watched against global feeds, new CVEs correlated with your results.
A current, submission-ready pentest report on demand at any point in the term.
Product-adjusted CVSSv3 and CVSSv4 for every finding, under FDA's MDDT program.
Remote testing of the physical device on your bench, out of band.
ELTON ONE is built for emerging and midsize manufacturers with a single product model.
The comprehensive test produces the premarket evidence: a pentest report with every finding rated on the MDDT-qualified rubric and traced to a digital-twin component. ELTON meets FDA premarket (Section 524B) and postmarket cybersecurity vulnerability testing and management requirements.
Postmarket runs on the same subscription: SBOM and hardware materials watched against global feeds, new CVEs correlated with your test results, and annual evidence of testing at regular intervals after release.
ELTON runs discovery and verification. Your regulatory and engineering people get the platform, the twin and the report, and nobody on the team has to become a pentester.
FDA expects regular testing after release; the subscription produces that evidence.
Onboarding happens once; after signature there is no SOW, PO or kickoff per test.
One product fits ELTON ONE; two products already need ENTERPRISE.
What does ELTON ONE include?
The full platform service for one product model for 12 months: a comprehensive test, the Digital Twin, continuous monitoring, living reports with MDDT-qualified ratings, and TestLink. One long-term commercial release is included.
What happens when we ship a new release?
It is added as needed and priced separately. ELTON already knows the product, so the new release tests only the change against the retained record.
When should we move to ELTON ENTERPRISE?
The moment you have two products. ENTERPRISE covers a portfolio on reserved lines under one agreement, and is cheaper per test once several products are tested a year.
Do we need our own OpenAI or Anthropic access?
No. Frontier models are used through ELTON's own access, which both companies reserve for verified defenders, so you get the same models without a license of your own. Prefer to keep everything local? Elect ELTON's open-weight models instead, or bring a model you already license.
Does ELTON ONE cover premarket and postmarket?
Yes. The subscription covers premarket and postmarket testing and vulnerability management for the product model, for the full 12-month term.
Does the device have to leave our building?
No. There are three ways to put the real device in the loop: ship it to ELTON's lab, have ELTON target the one in your lab remotely, or put TestLink on your bench and run it yourself. TestLink connects out of band over 5G, with no LAN, no VPN and no agents on your network.