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The Clinical Regulatory Knowledge Hub brings together expert insights on clinical evidence, clinical investigations, and post-market clinical activities for medical devices and IVDs. Explore practical guidance on topics such as PMCF, literature reviews, AI and clinical data, regulatory expectations under the MDR/IVDR, and emerging frameworks shaping clinical and regulatory strategy across the medical technology sector.
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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Use of artificial intelligence in literature screening for regulatory compliance
Discover how AI tools can streamline literature reviews for clinical evaluation Read More...
£50.00
The EU Data Act – how manufacturers lose control over connected device data
Prepare for the EU Data Act: explore how new data access and sharing obligations transform connected device governance and reshape manufacturers’ control of data Read More...
£40.00
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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The future European Health Data Space Act – a wealth of possibilities and risks
The EHDS Act is coming - are you ready? Discover the regulatory implications, opportunities, and challenges that will affect the medical device industry Read More...
£45.00
Clinical data and the federated learning concept for an AI/ML device
Understand how federated learning could be used to train AI/ML medical devices while protecting patients' health data Read More...
£40.00
An analysis of the EU MDCG recommendations concerning the content of a Clinical Investigation Plan and an Investigator’s Brochure
Ensure your clinical investigations meet EU expectations - this expert guide clarifies what regulators expect in both the CIP and Investigator’s Brochure Read More...
£45.00
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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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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