Investigating information systems with action research
Communications of the AIS
Software Risk Management: Principles and Practices
IEEE Software
A risk management capability model for use in medical device companies
Proceedings of the 2006 international workshop on Software quality
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Software is becoming an increasingly important aspect of medicaldevices (MDs) and MD regulation. MDs can only be marketed if complianceand approval is achieved from the appropriate regulatory bodies. MD companiesmust produce a design history file detailing the processes undertaken in thedesign and development of their MD software. The safety of all MD softwareproduced is of primary importance and it is crucial that an effective and efficientrisk management (RM) process is in place. The authors have developed asoftware process improvement RM model that integrates regulatory MD RMrequirements 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 improvedtheir RM process.