Current Edition

The Impact of Regulation on Software Development

The increasing array of regulation surrounding medical device design has as much impact on their software elements as the electronic and other physical components. Manufacturers must be able to document every significant action during the development process: where, when, how, what, by whom and why each change was made. Gerhard Kruger at Perforce Software discusses how the impact of regulation on software development presents a huge challenge in providing such evidence and one with which many organisations struggle.

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