Medi SPICE: An Overview

McCaffery, Fergal and Dorling, Alec (2009) Medi SPICE: An Overview. In: SPICE 2009 Conference.

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This paper outlines the development of a software process assessment and improvement model (Medi SPICE) specifically for the medical device industry. The paper details how medical device regulations may be satisfied by extending relevant practices from ISO/IEC 15504-5. 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. The Medi SPICE Process Assessment Model is based on ISO/IEC 15504-5: 2006 but will also provide coverage of additional software development practices that are required to achieve regulatory compliance within the medical device industry.

Item Type: Conference or Workshop Item (Paper)
Uncontrolled Keywords: Medical devices; Software; Medi Spice;
Subjects: Computer Science
Research Centres: Regulated Software Research Centre
Depositing User: Sonya Grimley
Date Deposited: 20 Feb 2012 09:10
Last Modified: 11 Nov 2014 16:10

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