Development and benefits of MDevSPICE®, the medical device software process assessment framework

摘要

Software development companies moving into the medical device domain often find themselvesrnoverwhelmed by the number of regulatory requirements they need to satisfy before they can market theirrndevice. Several international standards and guidance documents have been developed to help companiesrnon their road to regulatory compliance, but working their way through the various standards is a challengernin itself. In order to help software companies in the medical device domain, we have developed an integratedrnframework of medical device software development best practices called MDevSPICE®. This frameworkrnintegrates generic software development best practices with medical device standards’ requirements enablingrnconsistent assessment of medical device processes. MDevSPICE® can be used by software companiesrnevaluating their readiness for regulatory audits as well as by large medical device manufacturers forrnselecting suitable software suppliers.rnIn this paper, we describe the development of the MDevSPICE® framework—its process referencernmodel, process assessment model, assessment method and assessor training and certification scheme. Wernalso illustrate the benefits and significance of the framework for the medical device-manufacturing communityrnas learned from the various MDevSPICE® assessments that we conducted to date. Copyright © 2016rnJohn Wiley & Sons, Ltd.