Regulatory

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Understanding the New MDCG 2024-4 Guideline for IVD Safety Reporting

Published: May 21, 2024

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Microbial Identifications: Managing Bioburden Monitoring Results

Published: May 14, 2024

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A Product Development Plan For My Laboratory Developed Test

Published: May 10, 2024

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Navigating Medical Device Clinical Trial Site Selection: A Data-Driven Approach

Published: May 8, 2024

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Best Practices for MDR-Compliant Clinical Evaluations

Published: May 2, 2024

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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

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

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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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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