Abstract

This chapter considers medical device software development which takes place in a regulated environment. Research has shown that medical device regulations cannot be completely satisfied by generic software process improvement models. The development of a software process assessment model (Medi SPICE) specifically for the medical device industry through extending relevant practices from ISO/IEC 15504-5 is presented. Medi SPICE consists of a Process Reference Model and a Process Assessment Model. The Medi SPICE Process Assessment Model can be used to perform conformant assessments of the software process capability of medical device suppliers in accordance with the requirements of ISO/IEC 15504-2: 2003. The Medi SPICE Process Assessment Model is based on ISO/IEC 15504-5: 2006 but can also provide coverage of additional software development practices that are required to achieve regulatory compliance within the medical device industry.