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

摘要

A recent revision to the European Medical Device Directive (MDD) 2007/47/EC made 14 amendments to the original directive (93/42/EEC). A number of these changes directly affect the development of software for use in healthcare. The most significant change in relation to medical device software development is that stand-alone software is now seen as an active medical device and should be developed following state-of-the-art medical device software development processes. State-ofthe- art medical device software processes are understood within the industry as developing software in accordance with IEC 62304 and standards that are aligned with it. This study identifies how changes to the MDD affect medical device software development companies and recommendations are made as to how medical device software development companies can conform to the latest regulatory requirements. Additionally, the study provides an overview of how Medi SPICE is currently being developed to provide organisations with a single point of reference for the practices that should be implemented in order to produce regulatory compliant medical device software.