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 ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...