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 ...

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 ...

SAN DIEGO--(BUSINESS WIRE)--Bio-Matrix Scientific Group Inc. (OTCBB: BMSN), a biotechnology company focused on stem cell cryogenics and disposable stem cell/tissue transfer instruments, announced ...

Applying DOE and Risk-Assessment Methods Early Eases Process Validation However innovative or compelling a novel manufacturing process may be, its value depends on the ability to validate the process ...

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...