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Navigating the New MDCG Guidance Documents on CIP and IB

Published: May 1, 2024

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Understanding the ISO 18562:2024 Standards Update for Medical Devices

Published: April 17, 2024

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

Published: April 10, 2024

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

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

Published: April 5, 2024

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

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

Published: April 5, 2024

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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Medical Device Software: Considerations for Device and Risk Characterization

Published: April 2, 2024

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Revolutionizing Healthcare: The Rise of Medical Device Software and EU Regulatory Compliance

Published: March 26, 2024

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Will Vaporized Hydrogen Peroxide (VHP) Sterilization for Medical Devices Become More Common?

Published: March 20, 2024

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MDCG 2024-2: Procedures for the Updates of the European Medical Device Nomenclature

Published: March 13, 2024

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Industry Update: Quality Management System Regulation (QMSR)

Published: March 6, 2024

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Three Essentials for a Good Clinical Study Report

Published: February 29, 2024

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ASCA Accreditation: FDA Annual Report and NAMSA Customer Experience

Published: February 29, 2024

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MDR Vigilance: New MDCG Guidance Published

Published: February 13, 2024

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Embracing Digital Health Technologies: FDA’s New Guidance for Clinical Trials

Published: February 6, 2024

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