Medi SPICE : an update

This paper provides an update on the development of a software process assessment and improvement model (Medi SPICE) specifically for the medical device industry. The development of Medi SPICE was launched at the SPICE 2009 Conference. Medi SPICE will consist of a Process Reference Model and a Process Assessment Model. The Medi SPICE Process Assessment Model will 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. Some significant amendments have been made to the Medi SPICE architecture from what was proposed at the SPICE 2009 Conference. These amendments will be presented in this paper.