What Should Be Included in a Biological Evaluation Report (BER)?
Published: June 17, 2025
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Guide to Understanding the FDA Investigational Device Exemption (IDE) Process
Published: June 11, 2025
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Transforming Critical Care: The Advancements Driving Extracorporeal Membrane Oxygenation (ECMO) Technology Forward
Published: June 10, 2025
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Data and Safety Monitoring Boards (DSMBs) in Medical Device
Published: June 3, 2025
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Determining the Point of Exhaustion for Absorbable Medical Devices
Published: May 28, 2025
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Clinical Evaluation of Products Without Intended Medical Purpose
Published: May 22, 2025
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Guide to Premarket Approval (PMA) vs. De Novo: Understanding the Differences and Strategy
Published: May 21, 2025
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Five Mistakes to Avoid in Medical Device Clinical Trial Management and How to Fix Them
Published: May 6, 2025
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Top 6 Reasons Medical Device Proof-of-Concept Studies Fail
Published: April 30, 2025
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Guide to Clinical Evaluation Reports (CER) for Medical Devices
Published: April 17, 2025
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Guide to Understanding FDA Preclinical Study Requirements for Medical Devices
Published: April 10, 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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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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