About Sparta Care.

Founded in 2021, Sparta Care was born out of first-hand experience, as manufacturers, of the concrete challenges of CE marking for software. Before Sparta, we were on the other side : product and quality teams at health software publishers, trying to fit fast software releases into a regulatory framework designed for physical devices.

The first obstacle is always the same : sorting out, within a regulation designed for physical devices, what actually applies to software. MDR, IVDR, AI Act, harmonised standards, MDCG guidance, ANSM doctrine : the layers are dense, sometimes contradictory, and rarely written for software publishers. Teams spend weeks figuring out what concerns them before they can even start producing any evidence.

Then comes the operational mismatch. A software product evolves at the pace of fast releases, sometimes several per month. Compliance, on the other hand, requires documentary traceability that most manufacturers haven't designed to keep up with that pace. The whole challenge is therefore to regain flexibility : read the framework in its exact wording, identify the room for manoeuvre, and build a file that holds together without freezing the product. Without this, teams spend more time trying to understand the regulation than actually applying it day-to-day.

On top of this comes an acceleration that no framework had anticipated : the explosion of software embedding AI. Manufacturers now have to articulate MDR, IVDR and AI Act on a single product, with requirements that overlap, sometimes contradict each other, and notified bodies that are still building up expertise on these new objects. The result : a longer, more uncertain certification path, and a real risk of seeing useful innovations held back not by their clinical value, but by the illegibility of the regulatory journey.

Our conviction : software compliance will only scale by combining regulatory expertise and tooling. Forty missions later, this is what guides our practice. We support manufacturers through expertise, on reading the applicable framework, regulatory strategy and building the file, as well as through the Sparta Suite, which industrialises their QMS and enables them to maintain compliance over the long term.