Clinical & Consulting

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Components of Effective Clinical Trial Management

Posted 1 month ago

What is the Difference Between SiMD and SaMD?

Posted 2 months 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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Medical Device Reimbursement Payer Research: Key Areas of Payer Research

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

Posted 6 months ago

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A Product Development Plan For My Laboratory Developed Test

Posted 7 months ago

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Navigating Medical Device Clinical Trial Site Selection: A Data-Driven Approach

Posted 7 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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Collection of Race and Ethnicity Data in Clinical Studies – Standardizing the Sociocultural Construct of Our Society

Posted 8 months ago

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