Compliance, run
at the heart of your tools.

Alongside our services, we harness the power of AI to speed up obtaining and maintaining your CE marking. Classifying your device, keeping up with evolving regulations, querying your Quality Management System, preparing for the audit: each tool in the Sparta Care suite takes on a task that weighs on the daily work of regulatory teams.

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Ecosystem

Natively connected
to your stack.

Our tools plug directly into your existing environment. No parallel platform to manage, no data migration. Each component integrates right where your teams already work.

Confluence
Jira
Slack
Microsoft Teams
Google Drive
Notion
SharePoint
Sparta Care MD Assessment

Qualify and classify your software.

Assessment of whether your software qualifies as a Medical Device or not, followed by the determination of its associated class, based on your product description. An initial regulatory status is obtained within minutes, followed by a detailed rationale.

  • → MD or non-MD qualification (MDR 2017/745, IVDR 2017/746)
  • → Associated class determination (I, IIa, IIb, III or A, B, C, D)
  • → Structured classification rationale
Discover the assessment
Regulatory Assessment tool preview
Regulatory Monitoring

Synchro, filtered monitoring for software.

A weekly newsletter focused on software as medical devices. Each regulatory development is filtered and analyzed — you read what applies to your activity, without the usual noise from generic digests.

  • → Filtered exclusively for software medical devices
  • → Regulatory text analysis: what changes, concretely
  • → One delivery per week, short format
Discover Synchro
Synchro newsletter preview on mobile
Quality Management System

Your QMS, queryable from Teams and Slack.

A conversational assistant powered by your Quality Management System procedures. Your teams ask questions in natural language and get a sourced answer, without reopening a single document.

  • → Powered by your QMS procedures
  • → Sourced answers with exact passage citation
  • → Integrated into Teams and Slack
Discover the chatbot
Internal Audit

Identify gaps before the internal audit.

Analysis of your Quality Management System to identify gaps against the ISO 13485 standard. Potential non-conformities are ranked by criticality, ready to be addressed ahead of the internal audit.

  • → Gap identification against ISO 13485
  • → Non-conformities ranked by criticality
  • → Structured internal audit preparation
Discover Audit 360
Sovereign AI

A European AI, at the service of your compliance.

The Sparta Care Suite is powered by Mistral, the European sovereign LLM. A high-performing AI, rooted in the European artificial intelligence ecosystem.

Powered by
Mistral AI
01
Secure servers in Europe
Sovereign hosting, end-to-end encryption, GDPR compliant.
02
Zero data retention
Your documents are never stored or used to train the model.
03
Contractual confidentiality
Non-disclosure agreement signed before any documentation handover.
CTA Component — Sparta Care
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Let's talk about your device.

30 minutes to frame your needs.

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Certifications & partnerships
GMED certified
for QMS internal audit
BPI France
Experts