Loading...
MedeSPI: a software process improvement model for the medical device industry based upon Automotive SPICE
Date
2007
Abstract
Software is becoming an increasingly important aspect of medical devices and medical device regulation. Software enables highly complex systems to be built. However, complexity is the enemy of safety, therefore strict adherence to well documented processes is important within the domain of medical device software. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies (e.g. the Food and Drug Administration (FDA)) is achieved. This paper outlines the development of a software process improvement (SPI) model specifically for the medical device industry. The paper details how medical device regulations may be satisfied by extending relevant practices from Automotive SPICE.
Supervisor
Description
peer-reviewed
Publisher
Citation
Files
ULRR Identifiers
Funding code
Funding Information
Science Foundation Ireland (SFI)