Sparta Care — Experts du marquage CE des logiciels en santé
Sparta Care — Experts du marquage CE des logiciels en santé

Accelerating time to market
for digital health solutions
that drive healthcare forward.

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Experts in CE marking for software and AI systems in healthcare.

Sparta Care accelerates time to market for software and AI systems in healthcare. Our regulatory strategy and project methodology secure CE marking: your teams stay focused on the software, we handle compliance.

Teams supported
40+

Forty teams supported through their regulatory journey, across the full spectrum of software and AI medical devices.

Class IIa MDR
1st

First in France to obtain a Class IIa MDR CE mark for a software medical device.

Manon Marault — Talk Adopt AI, Grand Palais, Paris 2025
Adopt AI · Paris · 2025

What makes compliance so hard today.

The AI complexity

In the age of AI, the number of health software products is exploding. It has never been easier to build one — or harder to get it certified.

The regulatory maze

Between the AI Act, an evolving MDR, and national frameworks, the certification process has become nearly impossible to navigate.

The lost time

Regulatory dead ends, dragging timelines, Notified Bodies with unpredictable delays. Every month lost is a month without users.

Our services.

Sparta Care team in a working session on a CE marking timeline

We turn regulatory complexity into an execution roadmap. Framing the strategy before it drifts, structuring the Technical File in sync with the product, managing the relationship with the Notified Body, and sustaining the whole effort over time. As former manufacturers ourselves, we know what slows a submission down — and how to keep it moving.

Regulatory strategy

Classification, gap analysis, MDR / IVDR / AI Act roadmap. To start on solid ground.

CE marking

Technical File, ISO 13485 Quality Management System, Notified Body audit management. From first submission to certification.

eQMS implementation

Setup and maintenance of a digital Quality Management System. Accessible, living, compliant.

Internal audit

MDR 2017/745 and ISO 13485 compliant internal audits, led by GMED-certified auditors. To anticipate rather than react.

ANS compliance

Gap analysis and requirements assessment to achieve ANS compliance.
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Trusted by 40+ teams.

La Suite
Sparta Care.

En complément de nos services, nous mobilisons la puissance de l'IA pour accélérer l'obtention et le maintien de votre marquage CE. Classifier votre dispositif, suivre la réglementation qui évolue, interroger votre Système de Management de la Qualité, anticiper l'audit : chaque outil prend en charge une tâche qui pèse sur le quotidien des équipes réglementaires.

Évaluation I IIa IIb III

Évaluation réglementaire

Classifiez votre dispositif en quelques minutes. Un diagnostic en ligne pour cadrer la stratégie réglementaire avant d'engager les équipes.

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Veille

Synchro

Veille réglementaire automatisée sur MDR 2017/745, IVDR 2017/746 et IA Act. Une newsletter hebdomadaire qui filtre l'évolution du cadre : seules les mises à jour qui concernent votre dispositif.

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SMQ

Chatbot réglementaire

Assistant conversationnel entraîné sur votre Dossier Technique et votre Système de Management de la Qualité. Interrogez-le directement dans vos outils : la bonne réponse, citée à la source, en quelques secondes.

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Audit

Audit 360

Pré-audit complet de votre Système de Management de la Qualité. Une cartographie des non-conformités, hiérarchisée par criticité, prête à être traitée avant le passage de l'Organisme Notifié.

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Prendre rendez-vous Découvrir la Suite
Resources

Our insights.

Deep dives and analyses on CE marking for healthcare software.

The AI Act on 2 August 2026: What actually applies to medical device manufacturers, and what moves to 2028

The omnibus regulation (EU) 2026/1744 postpones the obligations on high-risk AI systems: August 2028 for AI embedded in medical devices. But 2 August 2026 remains a real deadline: transparency, authorities and penalties enter into application. What it means for SaMD manufacturers.

Elisa Negra
July 30, 2026

The basics of CE marking for Digital Medical Device manufacturers

CE marking is the gateway to the European market for any Digital Medical Device. Here is the path to MDR 2017/745 compliance in five clear steps, from classification to EUDAMED registration.

Elisa Negra
June 3, 2026

Bringing your SaMD to Europe: the essential steps for CE marking compliance

US SaMD manufacturer? Here are the 5 key steps to obtain CE marking and access the European market: QMS, classification, technical documentation, Notified Body and EUDAMED registration.

Maya Bouslimani
February 25, 2025
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GMED certified
for QMS internal audit
BPI France
Experts