Medical device regulation and AI

Clarify the regulatory status of your health solutions and accelerate their compliance.

We help your teams navigate regulatory requirements to turn compliance into a performance driver. By anchoring quality in your product cycles, you gain agility, reduce lead times and accelerate time to market.

Your main challenges

Becoming aware of regulatory status too late.

Discovering late that an innovative solution falls under the status of a medical device can upset an entire product strategy. This awareness leads to exploding costs, delays in getting to market and sometimes completely redesigning the software, compromising your development.

Compliance that seems out of reach.

CE marking, FDA clearance, MDR, IVDR, IVDR, ISO 13485, IEC 62304, IA Act... The texts are numerous, technical and demanding. For an unprepared company, this complexity of the normative framework becomes a real barrier to bringing digital health devices to the market.

A Quality Management System that slows down innovation.

When poorly designed, the Quality Management System (QMS) becomes a constraint. It makes processes heavier, slows compliance, discourages product improvement cycles, and wastes valuable time for your teams.

Our approach

Clarifier les exigences réglementaires dès le départ.

Nous animons des ateliers technico-réglementaires pour qualifier votre solution : statut, classe, exigences applicables. Cette étape préliminaire lève l’incertitude et permet de construire une roadmap progressive de conformité, alignée avec vos ambitions marché et vos priorités produit.

Concevoir un Système de Management de la Qualité utile, agile et intégré

Nous développons un SMQ sur mesure qui intègre les normes applicables (ISO 13485, IEC 62304, ISO 14971…) tout en respectant vos pratiques. Loin d’être une contrainte documentaire, il devient un outil de pilotage vivant qui soutient vos projets d’innovation.

Intégrer la conformité au développement produit.

Avec le Continuous Compliant Delivery, la conformité n’arrive pas en fin de parcours : elle est embarquée dans vos cycles de développement. Les preuves réglementaires sont générées en continu, avec une documentation automatisée par l’IA, assurant un dossier toujours à jour et des mises sur le marché plus rapides.

Align compliance and product performance.

Our expertise in the regulation of digital medical devices, certified ISO 13485, allows us to link normative requirements and business objectives. We have developed AI agents that incorporate all applicable standards and regulations. You reduce your deadlines, control your costs and secure your investments while remaining in compliance with European and American standards.