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Understanding the New FDA Draft Guidance for Chemical Characterization

Posted 21 days ago

What is the Difference Between SiMD and SaMD?

Posted 28 days ago

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

Posted 1 month ago

FDA’s Regulation of AI/ML SaMD

Posted 1 month ago

AI/ML and SaMD Medical Devices: New and Unique Challenges in Getting to Market

Posted 1 month ago

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Comparing US FDA vs EU MDR Medical Device Software Requirements

Posted 2 months ago

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Bioburden Testing vs. Sterility Testing: What Is The Difference?

Posted 2 months ago

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Medical Device Reimbursement Payer Research: Key Areas of Payer Research

Posted 3 months ago

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Navigating Biocompatibility in Early Feasibility Studies

Posted 3 months ago

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Summary of Safety and Clinical Performance Best Practices

Posted 3 months ago

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

Posted 3 months ago

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Wound Care Laboratory Testing Requirements: Your Path to Compliance

Posted 3 months ago

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

Posted 3 months ago

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Exploring Equivalency in Biocompatibility

Posted 3 months ago

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MDCG 2024-10 Clinical Evaluation of Orphan Medical Devices

Posted 4 months ago

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FDA Releases “Transparency of Machine Learning – Enabled Medical Devices: Guiding Principles”

Posted 4 months ago

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