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We Tested 24-Hour vs. 72-Hour Exhaustive Extraction Cycles for ISO 10993 Compliance

Published: March 25, 2026

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What Does FDA Breakthrough Device Designation Mean?

Published: March 18, 2026

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Ensuring Safety and Performance: Preclinical Approach to Structural Heart Device Testing

Published: March 11, 2026

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EDC Clinical Trials: Is Your EDC System Fit for Purpose?

Published: March 4, 2026

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The TEMPO Pilot Program: Key Strategic Guidance for Digital Health Manufacturers

Published: February 18, 2026

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From Study Design to Adjudication and Beyond: Building Robust Safety Strategies for Neurological Medical Devices

Published: February 11, 2026

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Guide to Reusable Medical Devices: Cleaning, Sterilization, and Disinfection Validations

Published: February 4, 2026

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Patient under medical imaging equipment; doctor in blue scrubs monitors screens.

FDA Real-World Evidence: What Does It Really Mean and How Does It Work?

Published: January 22, 2026

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Special Considerations for Preclinical Testing of Neurological Medical Devices

Published: January 21, 2026

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Why are Imaging Core Labs Essential for Medical Device Trials?

Published: January 14, 2026

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How the CER Connects with PSUR, PMCF, and SSCP

Published: January 7, 2026

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MDR: Aspirations vs. Reality in Notified Body Practice

Published: December 17, 2025

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Guide to Medical Device Prototyping: Tips to Optimize Preclinical Studies and Budgets

Published: December 9, 2025

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Medical Monitor in Clinical Trials for Medical Devices: Role and Importance

Published: December 2, 2025

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IVUS vs. OCT in Coronary Artery Imaging: A Comparative Insight

Published: November 11, 2025

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Woman looking at billing codes on computer

The Use of MedDRA Coding in Clinical Trials for MedTech and Medical Devices

Published: November 4, 2025

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