Managing requirements baselines for medical device software development

This paper outlines an approach taken to manage requirements baselines for regulated, Off-the-Shelf (OTS) software classified as a medical device, with on-going releases. This article is based on the authors´ experience at McKesson Enterprise Medical Imaging (EMI). The development and maintenance of OTS software requirements has challenges not found in typical custom development projects. In particular, as opposed to a single project delivering value to a specific customer (perhaps in phases, with a maintenance phase), the OTS software must satisfy multiple customers with on-going product releases, which build upon the previous releases. In the case of medical device software, there are additional regulatory controls that must be satisfied. The challenge then lies in how to manage the product requirements baselines in the face of the evolving releases, while satisfying both regulatory and safety constraints.