A Software Process Improvement Roadmap for IEC 62304: An Expert Review

Author:

Rust Peter,Flood Derek,Regan Gilbert,McCaffery Fergal

Publisher

Springer International Publishing

Reference20 articles.

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2. EU: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Off. J. Eur. Union L169 36, 1–60 (1993)

3. EU: Council Directive of 20 June 1990 on the approximation of the laws of the member states relating to active implantable medical devices (90/385/EEC). Off. J. Eur. Communities L189, 1–35 (1990)

4. Wallace, D.R., Kuhn, D.R.: Failure modes in medical device software: an analysis of 15 years of recall data. Int. J. Reliab. Qual. Saf. Eng. 8(4), 351–371 (1999)

5. EU: Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007. Off. J. Eur. Union L247, 21–55 (2007)

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