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This section provides complimentary access to expert articles and practical guidance on global medical device and IVD regulation. Explore free publications covering topics such as MDR/IVDR compliance, PMCF, software and digital health, sustainability, clinical evidence, and evolving international regulatory requirements impacting manufacturers and regulatory professionals worldwide.
Regulatory divergence of NIRS-based technologies: distinguishing cerebral oximeters and fNIRS devices under IEC 80601 standards
Understand how evolving IEC standards distinguish cerebral oximeters from fNIRS devices and the implications for regulatory submissions and device classification ** Available for pre-order - delivery date 31 August 2026 ** Pre-order now by clicking… Read More...
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Sufficient clinical evidence for medical devices – What is the role of post-market real-world data?
This article explores how post-market real-world data (RWD) can support the demonstration of sufficient clinical evidence for medical devices. Read More...
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High quality PMCF surveys under the EU MDR – from planning through to execution and data analysis
Ensure your PMCF surveys meet your regulatory needs - practical insights on planning, execution, and data analysis to stay MDR compliant Read More...
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Planning, designing and implementing high-quality (Level 4) post-market clinical follow-up surveys
Discover expert strategies for designing high-impact Level 4 PMCF surveys to improve post-market safety and performance Read More...
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Sustainability for the medical device industry – Concepts, global frameworks and EU regulatory requirements
Understand the latest sustainability trends and EU regulations shaping the future of the medical device industry Read More...
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Considerations for designing and implementing successful PMCF surveys
Ensure the success of your Post-Market Clinical Follow-up surveys with proven strategies for design and implementation Read More...
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