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

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

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© The Institution of Engineering and Technology
Published

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-of-the-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.

Inspec keywords: IEC standards; software process improvement; medical computing

Other keywords: healthcare; active medical device; software process improvement; medical device software development process; IEC 62304; medical device software development organisation; European medical device directive; stand alone software; regulatory compliant medical device software

Subjects: Software engineering techniques; Biology and medical computing

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