A recent standard for medical device software lifecycle processes, ISO/IEC 62304 (ISO 2006), assumes and specifies a software safety classification scheme, where documentation, verification and validation tasks to be carried out depend on the safety classification. This means that a risk-driven approach has become an accepted standard for medical devices. This paper describes how Systelab have progressively defined a quality system that integrates as core processes those specified by ISO 62304, and that applies a risk-driven approach also supporting processes such as contract and supplier management. © 2011 Springer-Verlag London Limited.
CITATION STYLE
Bianco, C. (2011). Integrating a risk-based approach and ISO 62304 into a quality system for medical devices. In Advances in Systems Safety - Proceedings of the 19th Safety-Critical Systems Symposium, SSS 2011 (pp. 111–125). Kluwer Academic Publishers. https://doi.org/10.1007/978-0-85729-133-2_7
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