Obtain the ANS certificate for your digital solution
Ensure your digital health solution fully meets the compliance requirements of the Agence du Numérique en Santé (ANS) to obtain the ANS certificate.
At Sparta Care, we guide you through this demanding process by structuring your dossier, analyzing gaps, and facilitating certification preparation.
Navigating ANS requirements
For many e-health startups, software publishers, or product teams, navigating the regulatory and technical expectations of the ANS is a major challenge. The Agence du Numérique en Santé is the French authority responsible for driving the digital transformation of the healthcare system and defining compliance frameworks for digital health solutions.
The most common obstacles are:
Accurately identifying the ANS requirements applicable to your digital solution.
Securing data and ensuring interoperability with national healthcare systems.
Ensuring your technical documents and internal procedures comply with the expected frameworks.
Structuring a clear, consistent, and complete dossier for the ANS evaluation.
An effective ANS compliance review
At Sparta Care, we analyze the expectations of the Agence du Numérique en Santé and strengthen your certification preparation through a compliance review tailored to your context, use cases, and objectives.
Requirements analysis and regulatory scoping
We clarify which ANS requirements apply to your solution, taking into account your product scope, its interfaces with healthcare systems, and the services and standards required by the ANS. This step precisely identifies the key points to address in your dossier.
Targeted document review
We examine your technical and organizational deliverables: functional description, health data security policy, interoperability and framework compliance, internal processes and associated documentation. The goal is to measure, for each requirement, the current compliance level and risk areas.
Compliance gap identification
For each relevant ANS criterion, we assess the degree of compliance, identify gaps against official expectations, and prioritize corrective actions by impact level. We identify, evaluate, and engage the relevant technical partners for your digital medical device to ensure effective and structured ANS compliance.
Who is this service for?
E-health startups and scale-ups looking to have their solution certified by the ANS.
Healthcare software publishers who want to secure their dossier before submission.
Technical and product teams who want to clearly understand the regulatory requirements.
We have supported them
To learn more, we recommend consulting: G_NIUS, Agence du Numérique en Santé
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