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 ...

The importance of ergonomics in hardware design is easy to grasp, if not always simple to carry out. The end goal is to make a device as easy and comfortable to use as possible, both physically 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 ...

We are living in an unprecedented era of rapid medical innovation in the face of COVID-19. The speed of development for devices and diagnostics has been driven by the urgency of the pandemic resulting ...