Rethinking Cytotoxicity: Do Cytotoxicity Results Predict In Vivo Outcomes?
Published: April 23, 2025
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The Newly Applied European Health Technology Assessment (HTA) Regulation: Implications for Medical Devices
Published: April 9, 2025
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ISO 10993-7 Primer: Testing for Ethylene Oxide Sterilization Residuals
Published: April 4, 2025
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Impact of FDA Changes on MedTech Research
Published: April 3, 2025
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FDA Real-World Evidence: What Does It Really Mean and How Does It Work?
Published: April 2, 2025
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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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A Guide to ISO 10993-18’s Analytical Evaluation Threshold
Published: November 21, 2024
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Enhancing Chemical Characterization with the CLAP Database
Published: November 14, 2024
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2 Regulatory Standards That Ensure Medical Devices are Transported and Stored Safely
Published: October 3, 2024
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Understanding the ISO 18562:2024 Standards Update for Medical Devices
Published: April 17, 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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MDCG 2024-2: Procedures for the Updates of the European Medical Device Nomenclature
Published: March 13, 2024
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