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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 international 80601 standards
Understand how evolving international standards distinguish cerebral oximeters from fNIRS devices and the implications for regulatory submissions and device classification 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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