ELTON ONE covers premarket and postmarket for a single product in one subscription. Platform subscriptions run about 60% less than a single FDA-required pentest procured through a consulting firm.
For a first submission
Premarket + continuous postmarket
Portfolios & top-10 makers
Pricing shown as tiers for illustration. Every plan includes the FDA-recognized MDDT methodology and evidence-backed dispositions. No engagement fees.
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.