In an increasingly demanding regulatory environment, the production of compliance documents represents a major challenge for medical device manufacturers. Between the need to guarantee impeccable quality, to meet standards requirements (MDR, ISO 13485, IEC 62304, etc.), and the imperative to innovate rapidly, the balance is difficult to strike.

Today, artificial intelligence (AI) is emerging as a powerful lever for facilitating document production while ensuring compliance. This presentation will explore how AI and intelligent bots can:
1. Assist in the creation of regulatory documents by automating the initial generation of content based on pre-identified requirements.
2. Check and validate the documents produced, quickly identifying deviations, inconsistencies or failures to comply with regulatory texts.
3. Optimize review and approval cycles, significantly reducing lead times while securing the quality of deliverables.

Through concrete examples and use cases, this presentation will demonstrate how these tools can transform document management into an agile, robust and compliant process. The result? Faster time-to-market for medical devices, while controlling risks and regulatory requirements.