Get ANS Certification for Your Digital Solution
Ensure that your digital health solution fully meets the compliance requirements of the Agence du Numérique en Santé (ANS) to obtain ANS certification.
At Sparta Care, we support you throughout this demanding process by structuring your documentation, analyzing gaps, and facilitating your preparation for certification.
The challenge
For many digital health startups, software publishers, and product teams, navigating the regulatory and technical requirements of the Agence du Numérique en Santé (ANS) represents 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 the compliance frameworks for digital health solutions.
The most common challenges are:
01
The precise identification of the ANS requirements applicable to your digital solution,
02
Data security and interoperability with national healthcare systems,
03
The compliance of your technical documentation and internal procedures with the required standards,
04
The structuring of a clear, consistent, and complete documentation for ANS evaluation.
Our approach: an efficient ANS compliance review
At Sparta Care, we analyze the requirements of the Agence du Numérique en Santé (ANS) 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,
- the services and standards required by the Agence du Numérique en Santé (ANS).
This step enables the precise identification of the key points to address in your documentation.
Targeted document review
We review your technical and organizational deliverables:
- functional description,
- health data security policy,
- interoperability and compliance with standards,
- internal processes and associated documentation.
The objective is to assess, for each requirement, the current level of compliance and the areas of risk.
Identification of compliance gaps
For each relevant ANS criterion, we:
- assess the level of compliance,
- identify gaps against official requirements,
- prioritize corrective actions based on their level of impact.
We identify, assess, and engage the
relevant technical partners for your digital medical device to ensure efficient and structured ANS compliance.
Who is this service for?
Digital health startups and scale-ups seeking ANS certification for their solution,
Healthcare software vendors seeking to secure their documentation before submission,
Technical and product teams seeking a precise understanding of regulatory requirements.
