Development in accordance with IEC 62304

Accelerate certification and marketing of your digital medical devices

We support health actors in the development and certification of digital medical devices. Our approach is based on implementing continuous compliance directly into your development, integration, and deployment (CI/CD) flow to accelerate delivery and market access.

Your main challenges

A complex regulatory framework that hampers innovation

Developing a digital medical device involves complying with strict standards (ISO 13485, IEC 62304, IEC 62366, ISO 14971, soon the IA Act). These requirements, which are essential to guarantee safety, extend validation cycles and delay the marketing of each product evolution.

Rare expertise that slows compliance

Ensuring the compliance of health software requires specific expertise: quality, regulation, risk management, clinical and usability. Bringing these skills together internally remains a real challenge. Without them, obtaining the CE mark or FDA authorization becomes an obstacle course that limits access to European and international markets.

Long and expensive regulatory procedures

Setting up a quality management system, structuring compliant processes and producing comprehensive documentation requires a considerable investment. For a single application, these efforts can span several years, creating a tension between regulatory requirements and economic viability.

Our approach

Intégrer la conformité en continu dans le développement

Notre approche Continuous Compliant Delivery combine design produit, ingénierie logicielle et expertise réglementaire. Inspirée des méthodes DevOps, elle permet de livrer fréquemment des versions logicielles tout en respectant rigoureusement les exigences des normes santé.

Automate traceability to simplify compliance

Each regulatory requirement is integrated into the code: each ticket becomes a documented proof, each test is automatically traced and updated. This continuous traceability ensures compliance that is always up to date, while reducing its cost and complexity. We support you at every stage, from the structuring of product requirements to the dialogue with your notified body, to obtain the CE mark and change the lives of patients.

Accélérer la documentation et les tests grâce à l’IA

Nos agents IA propriétaires accélèrent la rédaction des spécifications, la gestion des risques et les tests de vérification. Cette automatisation maîtrisée divise par vingt le temps nécessaire pour ces tâches, tout en conservant un contrôle humain systématique sur l’ensemble du processus.

Accompagner vos équipes du cadrage au marquage CE

Nos équipes vous accompagnent tout au long du projet : cadrage, développement, documentation, certification. Semaine après semaine, nous faisons avancer votre produit vers la mise sur le marché, sans rupture entre technique et réglementation.