Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL. Q. We are a well-established pharmaceutical ...

When developing software requirements it can be helpful to use existing products for inspiration. It is also useful to have several tools that can be used to manage those requirements. When ...

Some days, you wish you had telepathy. You just know that your development staff is holding back in some way, but you don’t know how to get them to communicate. Is the project in trouble, but they’re ...

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 ...