Name
Title | ||
|---|---|---|
Safety assessment of software-intensive medical devices: Introducing a safety quality model approach |
Abstract | ||
|---|---|---|
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. |
Year | DOI | Venue |
|---|---|---|
2013 | 10.1109/ISSREW.2013.6688901 | Software Reliability Engineering Workshops |
Keywords | Field | DocType |
biomedical equipment,medical computing,safety-critical software,software quality,argumentation structure,argumentation-based safety assurance,argumentation-based safety development,independent authority,safety assessment,safety quality model approach,software-intensive medical devices,medical software,safety assessment,safety case | Medical software,System safety,Software quality analyst,Computer science,Argumentation theory,Software,Safety case,Software quality,Safety assurance,Reliability engineering | Conference |
Citations | PageRank | References |
1 | 0.37 | 1 |
Authors | ||
4 | ||
Name | Order | Citations | PageRank |
|---|---|---|---|
| Rasmus Adler | 1 | 81 | 9.26 |
| Sören Kemmann | 2 | 1 | 0.37 |
| Djalma de Melo Carvalho Filho | 3 | 1 | 0.37 |
| José Augusto Oliveira Neto | 4 | 1 | 0.37 |