Summary Artificial intelligence is evolving faster than the regulatory frameworks around it. But that gap is beginning to close, with
Summary CE marking has long been associated with medical devices placed on the European market. As software has increasingly become
Summary An EU Authorised Representative plays a critical role for medical device and in vitro diagnostic manufacturers established outside the
Summary The MDR and IVDR have significantly changed the regulatory landscape for medical devices in Europe, extending responsibilities and liabilities
Summary Large Language Models (LLMs) are rapidly reshaping healthcare, supporting everything from administrative efficiency to clinical workflows. While their adoption
Summary The European Health Data Space (EHDS) Regulation represents a significant step towards creating a more connected and interoperable healthcare
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
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