User requirements form the essential building blocks for IT projects. Use these best practices to make sure you have a good set of requirements for your project. Managing user requirements is a ...

Proper planning and adherence to the key elements of effective device design transfer can aid any medical device company in creating an effective product. For the purposes of this article, design ...

A well-devised QPP, which has been agreed on and signed by both parties, saves time and makes it easier to complete activities such as design, installations and tests. Purified water (PW) is used in ...

Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical ...

Systems that are designed to “just work” for the end user (with the ability to install and run generic off-the-shelf operating systems out-of-the-box) need to follow a set of minimum hardware and ...