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 ...

If you are developing a medical device for the U.S. market, you first need to determine how your device will be classified by FDA. If you do not know the FDA classification, I recommend you go check ...

Design Reviews are intended to be checkpoints in a medical device product development to ensure the product design is safe, effective, and progressing. Design Reviews are also a way to ensure Design ...

FDA's quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the ...

Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design ...

Bioprocessing is an umbrella term that describes the research, development, manufacturing, and commercialization of products derived from or used by biological systems. For industrial purposes, ...