Summary Artificial intelligence is rapidly becoming part of the quality and regulatory landscape. From drafting procedures and technical documentation to
Summary The regulatory landscape for AI-enabled medical devices continues to evolve, and one of the latest developments attracting attention is
Summary Cybersecurity has become a central topic across the European digital regulatory landscape. While medical device manufacturers have already been
Summary The European Parliament’s proposal to move product-regulated AI systems from Section A to Section B of the AI Act
Summary When the MDR and IVDR entered into force, Article 5(5) created a specific framework for medical devices developed and
Summary By the time teams reach the submission phase, the assumption is often that the hardest decisions are behind them.
Summary In Part II of this series, Leon shifts the focus from initial regulatory positioning to one of the most
Summary FDA submissions for AI/ML-enabled medical devices rarely fail because of a single mistake – they unravel due to a
Where the European Medical Device Regulations (MDR 2017/745 & IVDR 2017/746) have significantly increased the regulatory burden for Legal Manufacturers
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