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
Software as a medical device (SaMD) is software intended to be used for one or more medical purposes that performs
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 Update, October 2026: Since this article was written, the draft has been published as EN 18286:2026, and the Commission
At MedQAIR, we know that strong regulatory and quality systems are built on both experience and continuous learning. As medical
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