Summary The regulatory landscape for AI-enabled medical devices continues to evolve, and one of the latest developments attracting attention is prEN 18286, the proposed European

Summary Cybersecurity has become a central topic across the European digital regulatory landscape. While medical device manufacturers have already been navigating cybersecurity requirements under the

Summary The European Parliament’s proposal to move product-regulated AI systems from Section A to Section B of the AI Act may initially sound like a

Summary When the MDR and IVDR entered into force, Article 5(5) created a specific framework for medical devices developed and used within health institutions. The

Summary By the time teams reach the submission phase, the assumption is often that the hardest decisions are behind them. In Part III, Leon challenges

Summary In Part II of this series, Leon shifts the focus from initial regulatory positioning to one of the most underestimated and often misused steps

Summary FDA submissions for AI/ML-enabled medical devices rarely fail because of a single mistake – they unravel due to a series of early assumptions that