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From Sketch to Surgery: The Journey of a Medical Device

Posted by Abby Kiliszewski Content on 4 Jun, 2026

Every device begins with an idea

Whether that be a drawing on a napkin when a thought appears or an inspiration coming from a clinician voicing their ...

How the FDA Classifies Medical Devices

Posted by Abby Kiliszewski Content on 17 Oct, 2025

Understanding Class I, II, III and Beyond 

A Beginner’s Guide to Navigating FDA Databases: Finding Device Clearances, Approvals, or Recalls

Posted by Abby Kiliszewski Content on 9 Oct, 2025

The U.S. Food and Drug Administration (FDA) is the federal agency responsible for protecting public health by ensuring that drugs, biologics, and medi...

How the FDA Approves Medical Devices

Posted by Abby Kiliszewski Content on 2 Oct, 2025

Introduction to Major Pathways 

Before medical devices in the United States are introduced to the market, they must first be approved by the Food and ...