Sparta Care — Experts du marquage CE des logiciels en santé

Accelerating the go-to-market
of digital solutions
that advance healthcare.

Experts in CE marking for healthcare software and AI systems.

Sparta Care accelerates the go-to-market of healthcare software and AI systems. 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 on their regulatory journey, across the full spectrum of software and AI devices.

Class IIa MDR

1st

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

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

What makes compliance so difficult today.

AI complexity

In the age of AI, the number of healthcare software products is exploding. It has never been easier to build one, nor harder to certify it.

Regulatory complexity

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

Wasted time

Regulatory wandering, drawn-out projects, Notified Bodies with unpredictable timelines. Every month lost is a month without users.

Our support.

Sparta Care team in a CE marking timeline work session

We turn regulatory complexity into an execution trajectory. Framing the strategy before it drifts, structuring the Technical File in sync with the product, managing the relationship with the Notified Body, and sustaining it all over time. As former manufacturers, we know what slows a dossier down and how to move it forward.

Regulatory strategy

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

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, conducted by GMED-certified auditors. To anticipate rather than react.

ANS compliance

Gap analysis and requirements assessment to achieve ANS compliance.

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They trust us. 40 teams supported.

The Sparta
Care Suite.

Alongside our services, we harness the power of AI to accelerate obtaining and maintaining your CE marking. Classify your device, track evolving regulations, query your Quality Management System, anticipate audits: each tool takes on a task that weighs on regulatory teams' daily workload.

Assessment

Regulatory assessment

Classify your device in minutes. An online diagnostic to frame the regulatory strategy before engaging teams.

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Monitoring

Synchro

Automated regulatory monitoring on MDR 2017/745, IVDR 2017/746 and the AI Act. A weekly newsletter that filters regulatory changes: only the updates relevant to your device.

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QMS

Regulatory chatbot

A conversational assistant trained on your Technical File and Quality Management System. Query it directly within your tools: the right answer, cited at the source, in seconds.

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Audit

360 Audit

A comprehensive pre-audit of your Quality Management System. A map of non-conformities, prioritized by criticality, ready to be addressed before the Notified Body visit.

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Resources

Our insights.

Deep dives and analyses on CE marking for healthcare software.

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

Expanding into Europe: the importance of an authorised representative for SaMD manufacturers

Non-EU SaMD manufacturers must appoint an Authorised Representative to access the European market. Role, responsibilities and regulatory obligations under article 11 of MDR 2017/745: what you need to know.

Maya Bouslimani

February 24, 2025

Medical software embedding AI: which rules and classifications you need to know

Diagnostic support algorithms, DTx, prescription software… How to obtain CE marking for a medical device embedding AI? Classification, compliance process and articulation with the AI Act: the complete overview.

Manon Marault

February 12, 2025

Browse our resources

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