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Development of MDevSPICE® – the medical device software process assessment framework
Author(s) -
Lepmets Marion,
Clarke Paul,
McCaffery Fergal,
Finnegan Anita,
Dorling Alec
Publication year - 2015
Publication title -
journal of software: evolution and process
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.371
H-Index - 29
eISSN - 2047-7481
pISSN - 2047-7473
DOI - 10.1002/smr.1731
Subject(s) - medical software , process (computing) , software , software engineering , computer science , medical device , personal software process , package development process , engineering management , software development process , software development , risk analysis (engineering) , systems engineering , process management , software construction , engineering , business , operating system , biomedical engineering
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.