Configuration management process improvement for the medical device industry

This paper outlines how the goals, practices and capability levels for the configuration management (CM) process area within a software process improvement (SPI) framework have been developed. This framework addresses an opportunity to integrate the regulatory issues and SPI mechanisms so as to achieve improvements that are critical to the development of software for medical devices [1]. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (FDA) [2] (US requirement), and the European Commission under its Medical Device Directives (MDD) [3] (CE marking requirement) is achieved. Integrated into the design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a design history file. Design history illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components.