Abstract Software that is incorporated into a medical device, or which is a standalone medical device in its own right, is of a safety critical nature and subject to regulation from various jurisdictions. In order to satisfy jurisdictional regulations, developers of medical device software adopt standards and guidance provided by international standards bodies and regulators. However, the various standards and guidance documents are often not developed as a single cohesive set resulting in a complex and costly challenge for medical device software developers when complying with regulation. The aim of this paper is to describe the integration of medical device guidance documents and software engineering standards into a unified framework for medical device software process assessment called MDevSPICE®. The paper illustrates the development of both the process reference model and the process assessment model (PAM) of MDevSPICE®. The MDevSPICE® PAM can help software developers to prepare for the regulatory audits, which they must satisfy as a prerequisite to placing their products on the market. The MDevSPICE® PAM can also assist medical device manufacturers to select competent software suppliers. Copyright © 2015 John Wiley & Sons, Ltd.

Abstract This article outlines the development of a software process assessment and improvement model (Medi SPICE) for the medical device industry. The article details how medical device regulations may be satisfied by extending relevant processes and practices from ISO/IEC 15504‐5. The article also describes the proposed phases of delivery for Medi SPICE. Medi SPICE will define a process reference model, process assessment model (PAM) and organizational maturity model (OMM). The Medi SPICE PAM will be used to perform ISO/IEC 15504 conformant assessments of the software process capability of medical device suppliers in accordance with the requirements of ISO/IEC 15504‐2: 2003. The Medi SPICE Process Assessment Model will be based on ISO/IEC 15504‐5: 2006 and shall be extended to provide coverage of additional software development practices that are required to achieve regulatory compliance within the medical device industry. The processes will be defined within an OMM conformant with ISO/IEC TR 15504‐7:2008. Copyright © 2009 John Wiley & Sons, Ltd.

In today's environment, when modern vehicles are increasing their reputation for performance, quality and value for money, succeeding in the market place is ever more dependent on the ability to employ new technology in all aspects of the business. It is widely understood that the quality of the end product can largely be determined by the quality of the processes which produce it. This paper discusses the impact of process standards on safety-related components and systems development in the automotive industry.

A survey has been designed to seek the practical foundation of base process activities (BPAs) in the software industry and to support research in modelling the software engineering processes. A superset of BPAs compatible with the current software process models, such as SPICE (ISO 15504), CMM, ISO 9000 and BOOTSTRAP, were identified for the construction of the questionnaires. This paper reports the survey findings on BPAs in software engineering processes. A summary of the current software engineering process techniques and practices modelled by 83 BPAs in 10 processes and three categories is given. Each BPA is benchmarked on attributes of mean importance and ratios of significance, practice and effectiveness. Based on the benchmarks, and by comparing with the current practice of the reader's organization, recommendations can be given on which specific areas need to have processes established first, and which areas should be highest priority for process improvement.