Managing Requirements for Medical IT Products

0 7 4 0 7 4 5 9 / 0 3 / $ 1 9 . 0 0 © 2 0 0 3 I E E E In the past, our team wrote many requirements documents at the start of a release project. This approach sometimes led to a bottleneck because the stakeholders who provided the content of product requirements were also needed for testing at the end of the previous release project. Our current approach recognizes that there is a continuous stream of new ideas for requirements from the outside world.1-3 We have built a process, supported by tools, in which we capture and refine requirements as they come in. In this way, we pool requirements ready for allocation to release projects. The requirements valid for the next release project are published in a document for that release. This process involves requirements analysts working closely with requirements stakeholders.