Producing quality software according to medical regulations for devices

Abstract

The US Food and Drug Administration and the European Community, through EC Directives, are requiring good manufacturing standards to be applied to the software development process. The creation of software is no longer to be treated as an art form, but as an engineering process. Previous descriptions of this process, as described by US MIL-STD 2167A or the IEEE guidelines, are applicable to the software development process for medical instruments. A brief description of this methodology is given, and the suitability of the Department of Defense methodology, including the Ada programming language, for developing medical device software is discussed.<>