Add to ORKGSoftware 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 ...
Software that is incorporated into a medical device, or which is a standalone medical device in its ...
For medical device organisations to market their devices in specific geographic regions they must ad...
Software that is incorporated into a medical device, or which is a standalone medical device in its ...
Software is becoming an increasingly important aspect of medical devices and medical device regulati...
Software is becoming an increasingly important aspect of medical devices and medical device regulati...
Software is becoming an increasingly important aspect of medical devices and medical device regulati...
The need for software is increasingly growing in the medical device industry. Even though the primar...
This paper describes a software process improvement framework to ensure regulatory compliance for th...
The need for software is increasingly growing in the medical device industry. Even though the primar...
For medical device organisations to market their devices in specific geographic regions they must ad...
This paper describes a software process development, assessment and improvement framework, structure...
This paper describes a software process development, assessment and improvement framework, structure...
peer-reviewedThis paper outlines how the goals, practices and capability levels for the configuratio...
peer-reviewedThe Medical Device industry is currently one of the fastest growing industries in the w...
The demand for medical device software continues to grow and there is an associated increase in its ...
Software that is incorporated into a medical device, or which is a standalone medical device in its ...
For medical device organisations to market their devices in specific geographic regions they must ad...
Software that is incorporated into a medical device, or which is a standalone medical device in its ...
Software is becoming an increasingly important aspect of medical devices and medical device regulati...
Software is becoming an increasingly important aspect of medical devices and medical device regulati...
Software is becoming an increasingly important aspect of medical devices and medical device regulati...
The need for software is increasingly growing in the medical device industry. Even though the primar...
This paper describes a software process improvement framework to ensure regulatory compliance for th...
The need for software is increasingly growing in the medical device industry. Even though the primar...
For medical device organisations to market their devices in specific geographic regions they must ad...
This paper describes a software process development, assessment and improvement framework, structure...
This paper describes a software process development, assessment and improvement framework, structure...
peer-reviewedThis paper outlines how the goals, practices and capability levels for the configuratio...
peer-reviewedThe Medical Device industry is currently one of the fastest growing industries in the w...
The demand for medical device software continues to grow and there is an associated increase in its ...
Software that is incorporated into a medical device, or which is a standalone medical device in its ...
For medical device organisations to market their devices in specific geographic regions they must ad...
Software that is incorporated into a medical device, or which is a standalone medical device in its ...