Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

This article is a condensed version of an article that appeared in the November/December 2022 issue of Chip Scale Review. Adapted with permission. Read the original ...

Practical guidance on how to handle validation failures cannot be found in the existing literature because they are not supposed to happen. Validation failures, just like out-of-specification (OOS) ...

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach. Parameters affecting cleaning ...

An expert illustrates why test method validation is important in the real world. José Ignacio Mora Tom was ready to send the multi-cavity fixtures. I asked him to perform a Gage Repeatability and ...

With the recent push by the EEOC for employers to use merit-based hiring to promote equal opportunity, the federal government is making it clear that employers should be using job-related, ...