Regulating manufacturing processes in the medical device industry is challenging. But process signature verification can help manufacturers get a handle on problems before they get out of control.

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...