The Software Requirement Specification as a Tool for Software Quality

摘要

This quality note is based on my practice as a medical device regulatory consultant who specializes in medical device software and focuses on smaller companies. This practical experience puts me in a strong position to make the comments in this article. In these small companies, good ideas abound, but the full range of needed technical expertise may not. Software, in particular, is seen as a black box that can be obtained from an outside source or a vendor. Just as large companies prefer to interact with other large companies, small companies tend to select small software houses to help get their innovative product built. In practical terms, this means the small team writing the software, often just one or two people, is not aware of good practices. I have seen situations where a software company is not really sure what regression testing is.