Safety assessment of software-intensive medical devices: Introducing a safety quality model approach

Argumentation-based safety assurance is a promising approach for the development of safe software-intensive medical devices. However, one challenge is safety assessment by an independent authority. This article presents an approach that enables argumentation-based safety development on the one hand, while providing means for assessing the product's safety afterwards on the other hand. We combine a generic safety case with an engineering model, which results in specific quality questions for assessors and provides a generic argumentation structure for manufacturers.