Role split
The line is explicit: the OEM is the legal manufacturer of the finished medical device, and we supply the software component, dataset-licence chain, and engineering documentation that feed their technical file.
Component vendor. Dossier-ready.
We do not place finished medical devices on the market. We deliver the engineering and documentation that makes our customers' submissions tractable.
Role split
What's in the dossier package
What's in the dossier package
The package is built to slot into an OEM technical file: SOUP declaration, model card, validation summary, IFU template, and training-data provenance records that document the chain from licensed data to shipped artifact.
Data posture
No PHI flows to us through the SDK. Datasets we hold are licensed with documented provenance, and any telemetry posture is opt-in and aggregated so OEM customers decide what operational signals they want to expose.
Quality system posture
Our operating posture is ISO 13485-aligned, IEC 62304-aware, and ISO 14971-aware. We frame quality work as an engineering discipline: release control, traceability, change management, and documentation that stands up to OEM review.
What we will not do
We will not make clinical claims, publish public performance numbers, or blur the line between software component and finished medical device. The OEM owns intended use, validation in context, and regulatory submission strategy.
Need a vendor posture your QA and regulatory teams can work with?
We can walk through the role split, dossier inputs, and evaluation path with your product and quality leads.