Development of MDevSPICE® – the medical device software process assessment framework

摘要

Software that is incorporated into a medical device, or which is a standalone medical device in its own right,rnis of a safety critical nature and subject to regulation from various jurisdictions. In order to satisfy jurisdictionalrnregulations, developers of medical device software adopt standards and guidance provided by internationalrnstandards bodies and regulators. However, the various standards and guidance documents are oftenrnnot developed as a single cohesive set resulting in a complex and costly challenge for medical device softwarerndevelopers when complying with regulation.rnThe aim of this paper is to describe the integration of medical device guidance documents and softwarernengineering standards into a unified framework for medical device software process assessment calledrnMDevSPICE®. The paper illustrates the development of both the process reference model and the processrnassessment model (PAM) of MDevSPICE®. The MDevSPICE® PAM can help software developers tornprepare for the regulatory audits, which they must satisfy as a prerequisite to placing their products on thernmarket. The MDevSPICE® PAM can also assist medical device manufacturers to select competent softwarernsuppliers. Copyright © 2015 John Wiley & Sons, Ltd.