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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...

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 ...

Why Your Designer Shouldn’t Love Your Idea as Much as You Do

Posted by Tyler Kiliszewski Content on 30 Jul, 2025

You’ve finally done it. After months, maybe even years, of dreaming, you’ve got your big idea. You sketch it out, tell your friends, and possibly file...

A New Direction in Medical Device Translation

Posted by Larry Kiliszewski Content on 18 Jul, 2022

In 2019, during a visit to Seattle Children's Hospital and Research Center, I was surprised to learn of the number of ideas and innovations that are b...