A proposed framework for software quality in the healthcare and medical industry.

In this paper, we propose a theoretical framework for software quality within the healthcare sector. The aim of this framework is to improve the quality of software produced within the healthcare and medical device industries, while assisting the manufacturers in achieving compliance with existing regulation. To develop this framework, we undertook an evaluation of the healthcare and medical legislation. This was followed by an evaluation of existing software quality standards and models. The CMMI model was chosen as the model on which to base this framework. An initial mapping between CMMI and the US FDA Code of Federal Regulations was undertaken. We present some of the examples the mapping here.