Simplify your regulatory watch with AI

Continuous and customized regulatory watch for Software as Medical Devices (SaMD).

Discover SYNCHRO

Your issue


Regulations governing Digital Medical Devices are constantly evolving. 


Staying up to date with MDR 2017/745, IVDR 2017/746, applicable ISO standards, and regulatory decisions is a strategic, burdensome, and time-consuming obligation.


It is mandatory for the Regulatory Compliance Officer (RCO), who must maintain a structured and specific monitoring system in order to anticipate developments affecting CE marking and market maintenance.

Our solution: SYNCHRO

 

We provide you with powerful, targeted, and immediately actionable regulatory watch digest based on intelligent sorting of information by AI and a rigorous human selection of reliable sources.


Thanks to AI based on reliable and verified regulatory sources, you can:

  • Eliminate noise and unreliable content
  • Anticipate regulatory changes
  • Ensure your products are compliant
  • Accelerate your time to market

We offer reliable, personalized, and immediately actionable technical monitoring.


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SYNCHRO by Sparta Care

A weekly digest covering updates to standards applicable to Software as a Medical Device (SaMD).

Key benefits of AI monitoring designed for startups and MedTech companies in digital health

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Intelligent Automation

Our AI continuously scans official publications, standards, decisions, and relevant updates without any action on your part.

Des fichiers de données liés à un dossier, illustrant l'organisation ou le stockage des données.

Verified & Reliable Sources

Unlike generic information feeds, each source is selected and sorted for regulatory relevance.

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Customized compliance

Receive only the alerts you need to comply with your regulatory obligations:

MDR/IVDR, ISO 13485, IEC 62304, CE compliance requirements, positions of Notified Bodies, the AI Act, regulatory developments directly impacting your compliance.


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Time savings & clarity

You avoid document overload and wasting time on manual searches.

Two options tailored to your needs

Essential Plan – Free

A comprehensive, structured, and reliable regulatory digest issued on a weekly basis.


Free content:

  • European regulatory news
  • Key decisions by the European Commission
  • Developments in MDR 2017/745 & IVDR 2017/746
  • News concerning MDs containing AI (AI Act)
  • Normative information (ISO 13485, etc.)


A solid foundation for staying informed effortlessly.

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Premium Package – Customized

Targeted regulatory watch tailored to your business, systems, and market context.


Premium content:

  • Specialized sources tailored to your specific field
  • Analysis of regulatory impacts on your products
  • Competitive regulatory analysis
  • Contextualization of risks and opportunities
  • Prioritization of critical alerts for your product strategy


Strategic regulatory watch, designed to help you anticipate and make decisions.


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Why does this solution change your approach?

In an industry where regulatory compliance is essential and every standard has an operational impact, SYNCHRO is designed to:

  • Reduce cognitive load

    Regulatory monitoring in the field of Digital Medical Devices is complex and time-consuming.

    Our artificial intelligence tool continuously analyzes European regulatory sources and filters out only the information that is truly relevant.


    You no longer waste time searching, reading, and sorting through information: the essentials are delivered directly to you in a clear and structured manner.

  • Promote quick and strategic decisions

    Dans un environnement réglementaire en constante évolution, la rapidité d’accès à l’information est clef.

    Notre solution vous permet d’identifier immédiatement les changements pouvant impacter vos produits, votre stratégie ou votre conformité.


    Vous disposez d’une information fiable, priorisée et exploitable pour prendre les bonnes décisions, au bon moment.

  • Moving from passive monitoring to proactive monitoring

    Rather than reacting to regulatory changes, our AI helps you anticipate them.

    It continuously monitors decisions made by authorities and regulatory and normative updates related to medical devices.


    You are alerted as soon as a change becomes relevant to your business.

    You can approach audits, CE marking, and MDR/IVDR changes with confidence.

  • Accelerate your compliance throughout the product lifecycle

    This AI monitoring service has been designed for companies that we support with CE marking and regulatory compliance.

    It fulfills an obligation: to stay constantly up to date, without mobilizing internal resources on a complex subject that is far removed from their core business.


    We do the monitoring and analysis work for you.

    You remain compliant and focused on innovation and product development.