Medi SPICE Development

McCaffery, Fergal and Dorling, Alec (2010) Medi SPICE Development. Software Process Maintenance and Evolution: Improvement and Practice Journal, 22 (4). pp. 255-268.

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This paper outlines the development of a software process assessment and improvement model (Medi SPICE) for the medical device industry. The paper details how medical device regulations may be satisfied by extending relevant processes and practices from ISO/IEC 15504-5. The paper also describes the proposed phases of delivery for Medi SPICE. Medi SPICE will define a a Process Reference Model (PRM), Process Assessment Model (PAM) and Organizational Maturity Model (OMM). The Medi SPICE Process Assessment Model 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 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 Organizational Maturity Model conformant with ISO/IEC TR 15504-7:2008.

Item Type: Article
Uncontrolled Keywords: Medi SPICE; Software Process Improvement (SPI); ISO/IEC 15504; FDA; Medical Device Directive; Medical Device Software Compliance; IEC 62304; Process reference model
Subjects: Computer Science
Research Centres: Regulated Software Research Centre
Depositing User: Sonya Grimley
Date Deposited: 09 Mar 2012 09:24
Last Modified: 11 Nov 2014 16:10

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