부산대학교 도서관

Software problem resolution and change control processes are crucial for the performance, safety, and regulatory clearance of a medical device. Software changes are frequent throughout the whole life cycle of a product; therefore, iterative analysis and risk assessment are necessary to determine the impact of changes on the whole system. IEC standard 62304 clarifies software medical device life cycle processes including problem and modification analysis and requirements. The aim of this work is to describe a cost‐effective and fully customizable solution for software medical devices problem and modification management implemented in our group. Key features of the problem and modification management related to the software life cycle have been identified and taken into account. A digital commercial platform for software development and maintenance has been identified and used to implement an architecture satisfying the standard. The architecture solution (SWMA, software maintenance architecture) has been successfully developed and a description of how it addresses IEC 62304 standard requirements both in terms of problem resolution and in terms of change control has been provided. The presented system can be useful for manufacturers/groups to establish software maintenance plans that include activities and tasks related to software problem resolution and change control processes. The approach can be adopted for analyzing and resolving problems arising before and after the release of a medical device. [ABSTRACT FROM AUTHOR]