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Doctor reviews notes at desk with medical tools, including test tubes and a stethoscope.

What Should Be Included in a Biological Evaluation Report (BER)?

Published: June 17, 2025

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White Paper: Toxicological Risk Assessment of Medical Devices

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Rethinking Cytotoxicity: Do Cytotoxicity Results Predict In Vivo Outcomes?

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The Newly Applied European Health Technology Assessment (HTA) Regulation: Implications for Medical Devices

Published: April 9, 2025

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

ISO 10993-7 Primer: Testing for Ethylene Oxide Sterilization Residuals

Published: April 4, 2025

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Impact of FDA Changes on MedTech Research

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Navigating the Regulatory Journey of Combination Products: A Focus on Material Characterization

Published: March 28, 2025

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Microchip with shield icon; digital circuit background, blue light highlighting connections.

FDA Premarket and Postmarket Medical Device Cybersecurity

Published: March 26, 2025

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A Guide to ISO 10993-18’s Analytical Evaluation Threshold

Published: November 21, 2024

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Medical professionals in blue scrubs and white coats collaborating, with a laptop.

Enhancing Chemical Characterization with the CLAP Database

Published: November 14, 2024

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

Published: October 3, 2024

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Understanding the ISO 18562:2024 Standards Update for Medical Devices

Published: April 17, 2024

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European Union blue flag with yellow stars waving in the wind, symbolizing NAMSA's work consulting on European Union medical device regulations

What Manufacturers Need to Know About the MDR Deadline Extension

Published: April 5, 2024

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Understanding ‘Assumed Release’ in ISO 10993-17:2023

Published: April 5, 2024

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What Could a PFAS Phase-out Mean for Medical Product Manufacturers?

Published: April 5, 2024

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Blue-gloved hands using a pipette to work with pink laboratory tubes.

Beyond Standard Testing: Exploring the Benefits of Custom Preclinical Solutions

Published: April 5, 2024

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