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

Published: March 28, 2025

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FDA Premarket and Postmarket Medical Device Cybersecurity

Published: March 26, 2025

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Key Components of a Biological Evaluation Plan (BEP)

Published: March 19, 2025

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Guide to Post-Market Clinical Follow-up Requirements Under EU MDR (2017/745)

Published: March 18, 2025

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Understanding the New FDA Draft Guidance on Medical Device Chemical Characterization

Published: March 14, 2025

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Impact of PFAS Regulations on Medical Devices

Published: March 11, 2025

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Pyrogen Testing for Medical Devices

Published: March 5, 2025

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Phthalates in Medical Devices: Context and European Regulatory Requirements

Published: February 19, 2025

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How to Ensure Compliance with Good Clinical Practices (GCP) in Clinical Trial Imaging

Published: February 5, 2025

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Bioburden vs. Bacterial Endotoxin Testing: Exploring Methods, Differences, and Laboratory Practices in Medical Devices

Published: January 29, 2025

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Periodic Summary Update Report (PSUR) & Post-Market Surveillance Report (PMSR) for MDR Compliance

Published: January 22, 2025

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Planning and Designing Medical Device Studies in Multiple Geographies

Published: January 15, 2025

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Histopathology in Focus: Evaluating Implanted Medical Devices

Published: January 9, 2025

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

Published: November 21, 2024

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Components of Effective Clinical Trial Management

Published: November 20, 2024

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Enhancing Chemical Characterization with the CLAP Database

Published: November 14, 2024

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