Improving Software Risk Management Practices in a Medical Device Company

Burton, John and McCaffery, Fergal and Richardson, Ita (2008) Improving Software Risk Management Practices in a Medical Device Company. In: International Conference on Software Process, ICPS 2008, May 10-11 2008, Leipzig, Germany.

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Software is becoming an increasingly important aspect of medical devices (MDs) and MD regulation. MDs can only be marketed if compliance and approval is achieved from the appropriate regulatory bodies. MD companies must produce a design history file detailing the processes undertaken in the design and development of their MD software. The safety of all MD software produced is of primary importance and it is crucial that an effective and efficient risk management (RM) process is in place. The authors have developed a software process improvement RM model that integrates regulatory MD RM requirements with the goals and practices of the Capability Maturity Model Integration (CMMI). This model is known as the RM Capability Model (RMCM). This paper evaluates how introducing the RMCM into a MD company improved their RM process.

Item Type: Conference or Workshop Item (Paper)
Additional Information: Springer Berlin/Heidelberg, Volume 5007/2008, ISSN 0302-9743 (print) 1611-3349 (online)
Uncontrolled Keywords: Risk Management; Process Assessment; Software Process Improvement; Medical Device Standards; Compliance; CMMI; FDA; BSI; Action Research; Evaluation; Verification
Subjects: Computer Science
Computer Science > Computer Software
Research Centres: Regulated Software Research Centre
Depositing User: Sonya Grimley
Date Deposited: 20 Feb 2012 09:08
Last Modified: 04 Dec 2015 14:18

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