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 ...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...

The "Process Validation with Qualification" conference has been added to Research and Markets' offering. Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to ...

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 ...

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 ...

Epic launched an open source tool on Wednesday to enable healthcare organizations to test and monitor artificial intelligence models. The AI validation software suite is free and available to the ...