Compliance, operated
at the heart of your tools.
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 in the Sparta Care suite takes on a task that weighs on regulatory teams' daily workload.
Qualify and classify your software.
Assessment of MD or non-MD qualification followed by determination of the associated class, based on your product description. An initial regulatory status is obtained in minutes, followed by an in-depth rationale.
- → MD or non-MD qualification (MDR 2017/745, IVDR 2017/746)
- → Determination of the associated class (I, IIa, IIb, III or A, B, C, D)
- → Structured classification rationale
Synchro, monitoring filtered for software.
A weekly newsletter focused on medical device software. Each regulatory change is filtered then decoded — you read what applies to your activity, without the usual noise of generalist digests.
- → Filtered for medical device software only
- → Decoding of texts: what changes, concretely
- → One delivery per week, short format
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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, exact passage citation
- → Integrated into Teams and Slack
Identify gaps against the standard before the internal audit.
Analysis of your Quality Management System to identify gaps against ISO 13485. Potential non-conformities are prioritized by criticality, ready to be addressed ahead of the internal audit.
- → Gap identification against ISO 13485
- → Non-conformities prioritized by criticality
- → Structured internal audit preparation
