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
Summary By the time teams reach the submission phase, the assumption is often that the hardest decisions are behind them.
Summary In Part II of this series, Leon shifts the focus from initial regulatory positioning to one of the most
Summary FDA submissions for AI/ML-enabled medical devices rarely fail because of a single mistake – they unravel due to a
At MedQAIR, we work with professionals who understand that regulatory and quality activities need to be embedded throughout the product
At MedQAIR, our work sits at the intersection of regulatory expertise, quality systems, and digital innovation. Supporting manufacturers of Software
In January 2024, the FDA issued a landmark Quality Management System Regulation (QMSR) final rule that overhauls 21 CFR Part
Introduction Medical device companies today face a complex web of regulations when marketing products globally. Unique Device Identification (UDI) systems
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