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

: Adler, R.; Kemmann, S.; Melo Carvalho Filho, D. de; Neto, J.A.O.


Institute of Electrical and Electronics Engineers -IEEE-:
IEEE International Symposium on Software Reliability Engineering Workshops, ISSREW 2013 : 4-7 November 2013, Pasadena, CA
Piscataway, NJ: IEEE, 2013
ISBN: 978-1-4799-2552-0
International Symposium on Software Reliability Engineering (ISSRE) <24, 2013, Pasadena/Calif.>
Fraunhofer IESE ()

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.