Implementation of a hybrid low overhead assessment method for medical device software development

Abstract

The need for software is increasingly growing in the medical device industry. Even though the primary concern of medical device software development is safety, medical device software development organisations are also concerned with time and budget overruns, plus ensuring that the customer requirements are fulfilled. At present the medical device software industry lacks strategies to combine adhering to mandatory regulatory guidelines with increasing the quality of the software developed. Software process improvement (SPI) assists software development organizations to increase their software quality, and assessments are an integral part of this process. Unfortunately, software process assessments are often expensive and time consuming. Additionally, they often provide companies with a long list of issues without providing realistic suggestions. The goal of this paper is to describe the implementation of a new low-overhead hybrid assessment method that has been designed specifically for medical device software development organisations wishing to improve their software development practices. This assessment method combines the SPI models of the Capability Maturity Model Integration (CMMI) and ISO/IEC 15504-5 with medical device software development regulations