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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...

Fail Fast, Fail Safe: The Engineering of Testing Medical Devices

Posted by Tyler Kiliszewski Content on 7 Oct, 2025

Instead of chasing perfection from day one, engineers know the real goal is getting perfection through failure quickly. That’s where the idea of “fail...

Risk Analysis in Medical Device Design: Why It Matters

Posted by Tyler Kiliszewski Content on 7 Oct, 2025

When it comes to medical devices, failure isn’t just a matter of inconvenience. Device failure can lead to serious harm to patients, regulatory roadbl...

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 ...