Top 6 Reasons Medical Device Proof-of-Concept Studies Fail
Published: April 30, 2025
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Rethinking Cytotoxicity: Do Cytotoxicity Results Predict In Vivo Outcomes?
Published: April 23, 2025
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ISO 10993-7 Primer: Testing for Ethylene Oxide Sterilization Residuals
Published: April 4, 2025
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Key Components of a Biological Evaluation Plan (BEP)
Published: March 19, 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Understanding the New FDA Draft Guidance on Medical Device Chemical Characterization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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Bioburden vs. Bacterial Endotoxin Testing: Exploring Methods, Differences, and Laboratory Practices in Medical Devices
Published: January 29, 2025
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A Guide to ISO 10993-18’s Analytical Evaluation Threshold
Published: November 21, 2024
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Making the Most of the Evolving Q-Sub Program
Published: October 3, 2024
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What Manufacturers Need to Know About the MDR Deadline Extension
Published: April 5, 2024
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Understanding ‘Assumed Release’ in ISO 10993-17:2023
Published: April 5, 2024
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What Could a PFAS Phase-out Mean for Medical Product Manufacturers?
Published: April 5, 2024
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Beyond Standard Testing: Exploring the Benefits of Custom Preclinical Solutions
Published: April 5, 2024
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Navigating Cytotoxicity Failures in Medical Devices: Comprehensive Risk Management Strategies
Published: November 3, 2023
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