Guide to Understanding the FDA Investigational Device Exemption (IDE) Process Published: June 11, 2025 View
Transforming Critical Care: The Advancements Driving Extracorporeal Membrane Oxygenation (ECMO) Technology Forward Published: June 10, 2025 View
Guide to Premarket Approval (PMA) vs. De Novo: Understanding the Differences and Strategy Published: May 21, 2025 View
Five Mistakes to Avoid in Medical Device Clinical Trial Management and How to Fix Them Published: May 6, 2025 View
Guide to Understanding FDA Preclinical Study Requirements for Medical Devices Published: April 10, 2025 View
The Newly Applied European Health Technology Assessment (HTA) Regulation: Implications for Medical Devices Published: April 9, 2025 View
FDA Real-World Evidence: What Does It Really Mean and How Does It Work? Published: April 2, 2025 View
Navigating the Regulatory Journey of Combination Products: A Focus on Material Characterization Published: March 28, 2025 View