We're building that layer. VarunaForge AI is independent validation infrastructure for AI in regulated environments — focused today on the manufacturers who feel the pressure first: makers of AI-enabled medical devices.
A regulated AI system needs continuous, independent proof that it still performs. Today that proof is bespoke, slow, and trapped inside single sites. We make it a standard — an independent cross-site benchmark, statistically rigorous drift detection, and a clean handoff into the manufacturer's own regulatory filing.
One independent standard a manufacturer, a notified body, and the FDA can all trust — the way regulated industries already rely on independent assurance everywhere else.
Founder-operator at the manufacturer–regulator control point.
25 years turning diagnostics into businesses.
Whether you're preparing for a post-market audit, already feeling field drift, or just want to see the monitoring in action — we'd value the conversation.