Project 06 · 2026–2028 · In progress

Ready for
every clinic.

A device can work perfectly in one lab and still not be ready for the world. This programme takes EVA beyond a single site and a single hand-built unit.

Project insight

Two things routine clinical use demands.

Production-representative batches of the device are manufactured and evaluated across multiple centres, demonstrating reproducibility and consistency at scale.

Reproducibility

The same result, whoever runs it, wherever, tested across independent sites rather than one controlled lab.

Consistency at scale

Every unit in a manufacturing batch behaving like the last, not just one hand-built prototype behaving well.

Why it matters

The evidence base for CE marking.

This is also the evidence base that underpins CE marking under EU MDR: performance shown not once, but reliably, across manufacturing batches and independent sites. Together with the commercial validation programme, it closes the gap between "it works in the study" and "it's ready for every clinic," positioning EVA to help double medically assisted reproduction success rates.

iProject info
Period
2026–2028
Programme
Bpifrance (BPI)
Regulatory target
CE marking, EU MDR
Keywords
Scale-up, reproducibility, CE marking, EU MDR
CE marking · EU MDRScale-up
Mr. Omar SaubryMr. Omar SaubryR&D Engineer Dr. Arnaud MauryDr. Arnaud MauryR&D Project Manager Dr. Shiva Kant ShuklaDr. Shiva Kant ShuklaPrincipal Investigator
Dissemination

Funded by Bpifrance.

Results feed directly into the regulatory dossier behind CE marking under EU MDR, the last step before EVA is ready for routine use in every clinic.

Bpifrance

Public financing and regulatory support for EVA's certification pathway.

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