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peer-reviewedA recent revision to the European Medical Device Directive (MDD) 2007/47/EC made fourteen\udamendments to the original directive (93/42/EEC). A number of these changes directly affect the development\udof software for use in healthcare. The most significant change in relation to medical device\udsoftware development is that standalone software is now seen as an active medical device and should\udbe developed following state of the art medical device software development processes. State of the\udart medical device software processes is understood within the industry as developing software in\udaccordance with IEC 62304 and standards that are aligned with it. This paper identifies how changes\udto the MDD affect medical device software development companies and recommendations are made\udas to how medical device software development companies can conform to the latest regulatory requirements.\udAdditionally, the paper provides an overview of how Medi SPICE is currently being developed\udto provide organisations with a single point of reference for the practices that should be implemented\udin order to produce regulatory compliant medical device software

Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive