Summary The European Commission’s proposed Digital Omnibus package could significantly reshape how the GDPR applies to medical device manufacturers, particularly those developing Software as a
Summary Artificial intelligence is rapidly becoming part of the quality and regulatory landscape. From drafting procedures and technical documentation to auditing management systems and analysing
Summary The regulatory landscape for AI-enabled medical devices continues to evolve, and one of the latest developments attracting attention is prEN 18286, the proposed European
At MedQAIR, we know that strong regulatory and quality systems are built on both experience and continuous learning. As medical devices, software, and AI-enabled technologies
Summary Cybersecurity has become a central topic across the European digital regulatory landscape. While medical device manufacturers have already been navigating cybersecurity requirements under the
Summary The European Parliament’s proposal to move product-regulated AI systems from Section A to Section B of the AI Act may initially sound like a
Summary When the MDR and IVDR entered into force, Article 5(5) created a specific framework for medical devices developed and used within health institutions. The
Summary By the time teams reach the submission phase, the assumption is often that the hardest decisions are behind them. In Part III, Leon challenges
Summary In Part II of this series, Leon shifts the focus from initial regulatory positioning to one of the most underestimated and often misused steps
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