Blogs

Introduction: Developing a medical device from an initial concept to a market-approved product is a journey that involves multiple stages of clinical research. Unlike pharmaceuticals (with Phase I–III trials), medical devices typically progress through a...

Dear Innovator, Are you preparing your medical device for EU MDR compliance? The Clinical Development Plan (CDP) is more than just a regulatory formality—it’s your blueprint for generating meaningful clinical evidence. At Bioexcel, we help...

When you're leading clinical operations and regulatory compliance like I am, there’s one scenario that plays in your head more often than you admit: The knock on the door. The demand for documentation. The fear...