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 ...

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 ...

Process validations are crucial when assessing and mitigating risks associated with manufactured medical devices. Basic steps can also be taken to improve problem-solving and root cause analysis. To ...