posted on 2012-07-04, 13:33authored byFergal Mc Caffery, Gerry Coleman
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 adopting relevant practices from the Capability Maturity Model Integration.
History
Publication
International Review on Computers and Software (IRECOS);2/1/pp 10-15