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Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model
2013
Computer Standards & Interfaces
Developing safety critical software is a complex process. Due to the fact that medical device software failure can lead to catastrophic consequences, numerous standards have been developed which govern software development in the medical device domain. Risk management has an important role in medical device software development as it is important to ensure that safe software is developed. Demonstrating traceability of requirements right throughout the medical device software development and
doi:10.1016/j.csi.2013.07.012
fatcat:hpujdnizvng7bclwqm6c4vqoou