The US Food and Drug Administration (FDA) has issued four medical device-related guidance documents. The new guidances address brain-computer interfaces, considerations in medical device design for ...

In medical device development, packaging is often treated as a finishing step. Once a sterile barrier passes seal strength testing, aging, and simulated distribution, it is generally considered ...

The effect of incomplete or insufficient testing of products is directly felt in the areas of product quality, support costs, and, in the worst cases, patient safety. However, the increasing software ...