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A software process development,assessment and improvement framework,for the medical device industry
Date
2004
Abstract
This paper describes a software process development, assessment and improvement framework, structured to ensure regulatory compliance for the software developed in medical devices. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (US requirement), and the European Commission under its Medical Device Directives (CE marking requirement) is achieved. Integrated into the design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a design history file. Design history illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components.
Supervisor
Description
peer-reviewed
Publisher
Citation
4th International SPICE Conference on Process Assessment and Improvement; pp 100-109
Files
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2004_McCaffery.pdf
Adobe PDF, 463.15 KB
Keywords
ULRR Identifiers
Funding code
Funding Information
Science Foundation Ireland (SFI)