Over the years, technological advancements have enabled the development of a variety of versatile medical devices, offering various specialized features, for various drug delivery and disease ...

Customers have been frustrated, injured and even killed by confusing instructions, unclear operating procedures and poorly designed controls. In some cases, these interfaces and instructions were ...

Replacing a draft guidance issued in February 2016, FDA recently finalized its guidance on the use of human factors engineering (HFE) in the development of combination medical devices with a drug or ...