European Market

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Components of Effective Clinical Trial Management

Posted 1 month ago

EU MDR and IVDR: Classifying Medical Device Software (MDSW)

Posted 2 months ago

FDA’s Regulation of AI/ML SaMD

Posted 2 months ago

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Comparing US FDA vs EU MDR Medical Device Software Requirements

Posted 4 months ago

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Summary of Safety and Clinical Performance Best Practices

Posted 5 months ago

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When, Why, and How to Use Post-Market Clinical Follow-Up (PMCF) Surveys

Posted 5 months ago

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Real-World PMCF Under the MDR: Cost Effective PMCF Strategies and Plans

Posted 5 months ago

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MDCG 2024-10 Clinical Evaluation of Orphan Medical Devices

Posted 5 months ago

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MHRA Statement of Policy Intent: International Recognition of Medical Devices

Posted 6 months ago

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Understanding the Benefit-Risk Ratio in Clinical Reports: Avoiding 6 Common Mistakes

Posted 6 months ago

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Best Practices for MDR-Compliant Clinical Evaluations

Posted 7 months ago

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Navigating the New MDCG Guidance Documents on CIP and IB

Posted 7 months ago

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MDCG 2024-2: Procedures for the Updates of the European Medical Device Nomenclature

Posted 9 months ago

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MDR Vigilance: New MDCG Guidance Published

Posted 10 months ago

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European Commission Updates Chemical Classification and Labeling

Posted 10 months ago

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Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR

Posted 10 months ago

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