A Software Process Improvement Roadmap for IEC 62304: an Expert Review

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 im-plementation 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

Software developers reasoning behind adoption and use of software development methods – a systematic literature review

When adopting and using a Software Development Method (SDM), it is important to stay true to the philosophy of the method; otherwise, software developers might execute activities that do not lead to the intended outcomes. Currently, no overview of SDM research addresses software developers’ reasoning behind adopting and using SDMs. Accordingly, this paper aims to survey existing SDM research to scrutinize the current knowledge base on software developers’ type of reasoning behind SDM adoption and use. We executed a systematic literature review and analyzed existing research using two steps. First, we classified papers based on what type of reasoning was addressed regarding SDM adoption and use: rational, irrational, and non-rational. Second, we made a thematic synthesis across these three types of reasoning to provide a more detailed characterization of the existing research. We elicited 28 studies addressing software developers’ reasoning and identified five research themes. Building on these themes, we framed four future research directions with four broad research questions, which can be used as a basis for future research