How the FDA Classifies Medical Devices

Posted by Abby Kiliszewski Content on 17 Oct, 2025

Understanding Class I, II, III and Beyond

Topics

Inventor Resources, Regulatory, FDA

Plastics in Medical Devices

Posted by Arin Holecek Content on 14 Jul, 2020

There are a wide range of plastics that can be used in medical devices. Plastic selection depends on application as well as cost and manufacturability...

Topics

Device Design, Mechanical Engineering, Biomedical Engineering, Materials

A Look at a Common Medical Device Design Challenge, Tolerance Stack-ups.

Posted by Arin Holecek Content on 3 Mar, 2020

“A common practice among engineers is to put together a prototype of an assembly with every part very close to the nominal or intended measured charac...

Topics

Device Design, Mechanical Engineering, Biomedical Engineering, Software, Materials

Blog Articles

How the FDA Classifies Medical Devices

Plastics in Medical Devices

A Look at a Common Medical Device Design Challenge, Tolerance Stack-ups.

Recent posts