Software as a medical device (SaMD) has to meet the same technical documentation obligations as any other device under
Summary An EU Authorised Representative plays a critical role for medical device and in vitro diagnostic manufacturers established outside the
A medical device quality system has to do more than document procedures. It needs to give an organisation a controlled
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
An overview of the first episode of NEN’s podcast on AI in healthcare AI keeps turning up across everyday care,
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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