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White Paper: Navigating Dual Regulations: Strategies for IVD Market Approval in China and the EU

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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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The Importance of Selecting the Right Partner

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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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Strategies for Selecting the Proper Investigational Sites for Pivotal Studies

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Risk Management, Clinical Evidence and Post-Market Reporting

Published: March 6, 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

ASCA Accreditation: FDA Annual Report and NAMSA Customer Experience

Published: February 29, 2024

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NAMSA’s Clinical Research Capabilities

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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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European Commission Updates Chemical Classification and Labeling

Published: February 2, 2024

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The Value of Market Insights

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