• Medi SPICE;
  • software process improvement;
  • ISO/IEC 15504;
  • FDA;
  • medical device directive;
  • medical device software compliance;
  • IEC 62304


This article outlines the development of a software process assessment and improvement model (Medi SPICE) for the medical device industry. The article details how medical device regulations may be satisfied by extending relevant processes and practices from ISO/IEC 15504-5. The article also describes the proposed phases of delivery for Medi SPICE.

Medi SPICE will define a process reference model, process assessment model (PAM) and organizational maturity model (OMM). The Medi SPICE PAM will be used to perform ISO/IEC 15504 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 will be based on ISO/IEC 15504-5: 2006 and shall be extended to provide coverage of additional software development practices that are required to achieve regulatory compliance within the medical device industry. The processes will be defined within an OMM conformant with ISO/IEC TR 15504-7:2008. Copyright © 2009 John Wiley & Sons, Ltd.