Implementation of a lightweight assessment method for medical device software

Abstract

This paper outlines the development and implementation of Medi SPICE-Adept. Medi SPICE-Adept is a lightweight assessment method that has been designed for usage with the Medi SPICE software process assessment and improvement model which is currently being developed for the medical device industry. While the Medi SPICE model is detailed and comprehensive in its approach there is industry demand for a lightweight medical device process assessment and improvement method. To address this requirement Medi SPICE-Adept has been developed. Details on how this has taken place and the procedures for implementing a Medi SPICE-Adept assessment are presented. Information is also provided regarding how a Medi SPICE-Adept assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this assessment and the actions taken to facilitate process improvement is also presented. Finally, plans for future work are discussed.