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MedeSPI: a software process improvement model for the medical device industry based upon Automotive SPICE

Creator:

Mc Caffery, Fergal; Richardson, Ita;

Subject Keywords: medical devices; software process improvement; FDA;
Region:
Description:

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.

Suggested citation:

Mc Caffery, Fergal; Richardson, Ita; . () MedeSPI: a software process improvement model for the medical device industry based upon Automotive SPICE [Online]. Available from: http://publichealthwell.ie/node/648360 [Accessed: 26th June 2019].

  

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