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CNC vs. Injection Molding: Which Is Right for Your Medical Device?

Posted by Tyler Kiliszewski Content on 4 Nov, 2025

When designing a medical device, every decision matters. But when it comes to manufacturing, few decisions are as pivotal as choosing between CNC mach...

From Idea to Market: How Long It Really Takes to Develop a Medical Device

Posted by Abby Kiliszewski Content on 23 Oct, 2025

Bringing a medical device from thought to market is an extensive process; even with the shortest timelines, considering the different types of devices...

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 ...