Abstract

The difficulty of complying with different regulations is becoming more evident as larger numbers of regulated businesses are mandated to follow a set of different regulations in their prescribed boundaries. This wide spectrum of regulations is inevitable as the result of today's heavily regulated society. In this thesis, we focus on the Food and Drug Administration (FDA) regulations and their impact on software development. FDA mandates stringent requirements on the process by which software systems for medical devices are developed. Many of these requirements involve documenting various activities in the software process, something that agile processes such as the Extreme Programming (XP) process do not support. In this thesis, we discuss FDA requirements in detail and relate these requirements to software engineering practices. We then show areas where XP fails to meet these requirements. We propose an extension to XP that complies with FDA. The extended process is implemented using the Eclipse Process Framework (EPF). A questionnaire-based evaluation technique is used to validate the extended XP.