Abstract
Manufacturers of medical devices must comply with certain legislation and regulations before they can market their products in the European Union (EU). The EU has introduced this legislation and regulation to provide the frameworks by which manufacturers can produce safe and effective medical devices in a consistent manner. The EU has accomplished this by way of Medical Device Directives and harmonised standards. Manufactures, by demonstrating compliance with a harmonised standard, can be presumed to have complied with the essential requirements of the legislation. IEC 62304 Medical device software – Software lifecycle processes is a harmonised standard. However, the standard provides no clear directions for meeting the requirements of the standard. A Software Process Improvement (SPI) Roadmap for IEC 62304:2006 has been developed as a method for aiding medical device software development organizations in implementing the standard. The Roadmap is divided into two levels, the high level consists of the Activities and Tasks necessary for the implementation of the standard, while the low level contains the Design Patterns and How-to artefacts linked to the Tasks. This paper presents the findings from the expert review of the high level roadmap.
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Acknowledgement
This work was supported with the financial support of the Science Foundation Ireland grant 13/RC/2094 and co-funded under the European Regional Development Fund through the Southern & Eastern Regional Operational Programme to Lero - the Irish Software Research Centre (www.lero.ie). This work was partly funded by the DEIS H2020 project (Grant Agreement 732242).
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Rust, P., Flood, D., Regan, G., McCaffery, F. (2018). A Software Process Improvement Roadmap for IEC 62304: An Expert Review. In: Larrucea, X., Santamaria, I., O'Connor, R., Messnarz, R. (eds) Systems, Software and Services Process Improvement. EuroSPI 2018. Communications in Computer and Information Science, vol 896. Springer, Cham. https://doi.org/10.1007/978-3-319-97925-0_50
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