One of the primary objectives for the application of flow cytometry in any testing environment should be measurement assurance, i.e., the generation of reliable and reproducible results. This goal can ...

If you’re in the medical device industry, you may think that design controls are a confusing imposition on your process. They’re a necessary part of your requirements as a medical device developer and ...

Medical device manufacturers have a bit of latitude in developing a design control system as long as they meet the minimum criteria delineated in the quality system regulation (QSR). The QSR states ...