For AI-enabled medical devices

Built for medical-device AI. Whatever it does.

If your device uses AI to read an image or reach a diagnostic decision, and a regulator expects continuing proof it still performs, VarunaForge AI fits. The engine is device-agnostic; the obligation is not. Same method, any modality.

One problem, every modality

The drift is the same wherever AI meets a regulated decision.

The metric differs by device — sensitivity, specificity, concordance, time-to-result. The need doesn't: an independent, ongoing benchmark that proves the model still performs in the real world, against the claim it was cleared on.

Imaging AI

It reads an image

Pathology, radiology, ophthalmology, dermatology, cardiology, oncology — wherever a model interprets an image, performance moves with the scanner, the site, and the population. We track it against the registered claim.

Diagnostic & IVD AI

It reaches a result

Where a model produces a diagnostic, prognostic, or measurement output, drift travels with the population, the instrument, and the workflow. The same independent benchmark applies.

Any cleared device

It carries a claim

If your device has a validated performance claim, it can drift away from it — and it can be watched. The engine adapts to the metric that matters for your device, not the other way round.

What you get

The same four things, whatever your device does.

01

An independent benchmark

A cross-site reference you can't build from your own deployments — the only place an objective read on your real-world performance can come from.

02

Statistically defensible detection

Sensitivity and specificity tracked with confidence intervals, not a single number, so a flag means a real, sustained move outside the expected range — not noise.

03

Audit-ready evidence

Output that drops straight into your post-market file for your notified body or the FDA — proactive, deliberately collected, and yours to own.

04

A low-friction start

The first engagement runs on your own retrospective validation data — no hospital integration, no live data plumbing, no disruption to your team.

Where does your device sit?

Tell us what your device does and where you are with post-market evidence, and we'll show you what independent monitoring looks like against your own validation data.