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Scientists reviewing brain scan images on computer screens in a lab setting.

How to Ensure Compliance with Good Clinical Practices (GCP) in Clinical Trial Imaging

Published: February 5, 2025

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Person in blue uniform writing notes on a clipboard in a medical setting.

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

Published: January 22, 2025

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Blue-toned image of Earth from space, with glowing network lines around it representing NAMSA's global reach in medical device studies.

Planning and Designing Medical Device Studies in Multiple Geographies

Published: January 15, 2025

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Two people in suits working on a laptop at a long table with pendant lights representing a NAMSA blog post about the difference between SiMD and SaMD

Components of Effective Clinical Trial Management

Published: November 20, 2024

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Making the Most of the Evolving Q-Sub Program

Published: October 3, 2024

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Person holding a pink petri dish and a blue tool, wearing blue gloves. Illustration of NAMSA's sterility testing services.

2 Regulatory Standards That Ensure Medical Devices are Transported and Stored Safely

Published: October 3, 2024

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What is the Difference Between SiMD and SaMD?

Published: October 2, 2024

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Smartphone displaying data next to a digital scale with a turquoise screen representing a NAMSA blog post about the EU MDR and IVDR's classification of medical devices

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

Published: September 25, 2024

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People analyzing data on a computer screen, overlaid with digital graphics and charts representing a NAMSA blog post on FDA regulations of AI, Machine Learning, and SaMD

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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