Development of a process assessment model for medical device software development

Software that is incorporated into a medical device, or which is a standalone medical device in its own right, is of a safety critical nature and subject to regulation from various jurisdictions (principally the EU and the US). In order to satisfy jurisdictional regulations, developers of medical device software generally implement standards and guidance provided by internation-al standards bodies and national administrative departments. However, the various standards and guidance documents are not developed as a single cohesive set but often as separate re-sources addressing distinct areas of concern. The result for medical device software develop-ers is that integration of these various sources represents a challenging undertaking. The aim of this paper is to describe the integration of the several process models and regula-tory standards, first, into a process reference model and then into a process assessment model for medical device software development. The focus is on the integration of regulatory standards from the medical device domain with generic software development process mod-els, resulting in a unified best practice framework for medical device software development. The process reference model for medical device software development is going to be pub-lished this year as IEC TR 80002-3, and the process assessment model for medical device software development is currently being validated through pilot studies in medical device in-dustry. This best practice framework will help small software developers in their adoption of regula-tions-compliant best practices while reducing the overhead associated with understanding the long list of regulations and standards they need to adhere to when developing software for medical devices. This framework will also help the manufacturers in selecting their software suppliers assuring that the suppliers have adopted the best practices and are compliant with the medical device standards and regulations.