Document Type

Article

Rights

This item is available under a Creative Commons License for non-commercial use only

Disciplines

Computer Sciences

Publication Details

IET Software Special Issue on European Software Process Improvement. Vol. 6, Issue 5, 2012.

Abstract

A recent revision to the European Medical Device Directive (MDD) 2007/47/EC made fourteen 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 standalone 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 is understood within the industry as developing software in accordance with IEC 62304 and standards that are aligned with it. This paper 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 paper 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.

DOI

10.1049/iet-sen.2011.0198

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