Development of the medi SPICE PRM

Abstract

As the importance and complexity of medical device software continues to increase there is growing demand for effective process assessment and improvement in this domain. To address this need the Medi SPICE process assessment and improvement model is being developed. Regulatory compliance is both an important and challenging aspect of medical device software development. Particularly as new regulations are being released and existing standards revised due to the attention that software is receiving within the health domain. To comply with these latest developments the Medi SPICE Process Reference Model (PRM) is being developed to conform with ISO/IEC 12207:2008 and the forthcoming release of ISO/IEC 15504-5 (currently under ballot). This paper outlines the development of the Medi SPICE PRM. It also provides details of the schedule for the full release of the Medi SPICE model. © 2012 Springer-Verlag.