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Periodic Summary Update Report (PSUR) & Post-Market Surveillance Report (PMSR) for MDR Compliance

Published: January 22, 2025

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Planning and Designing Medical Device Studies in Multiple Geographies

Published: January 15, 2025

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Histopathology in Focus: Evaluating Implanted Medical Devices

Published: January 9, 2025

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Components of Effective Clinical Trial Management

Published: November 20, 2024

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What is the Difference Between SiMD and SaMD?

Published: October 2, 2024

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

Published: September 25, 2024

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FDA’s Regulation of AI/ML SaMD

Published: September 25, 2024

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Comparing US FDA vs EU MDR Medical Device Software Requirements

Published: August 13, 2024

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

Published: August 6, 2024

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Medical Device Reimbursement Payer Research: Key Areas of Payer Research

Published: July 31, 2024

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Summary of Safety and Clinical Performance Best Practices

Published: July 24, 2024

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

Published: July 17, 2024

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

Published: July 10, 2024

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MDCG 2024-10 Clinical Evaluation of Orphan Medical Devices

Published: July 1, 2024

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

Published: June 26, 2024

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MHRA Statement of Policy Intent: International Recognition of Medical Devices

Published: June 13, 2024

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