Summary The EU Commission SaMD proposal introduces significant changes that could reshape the regulatory landscape for Software as a Medical
Summary Medical Device QMS requirements are evolving as third-party large language models (LLMs) become part of AI-enabled medical devices. While
Summary AI Regulation for AI-enabled medical devices is entering a period of significant change. While the European Commission has proposed
Summary The European Commission’s proposed Digital Omnibus package could significantly reshape how the GDPR applies to medical device manufacturers, particularly
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
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