Risk management capability model for the development of medical device software

Author:

Mc Caffery Fergal,Burton John,Richardson Ita

Publisher

Springer Science and Business Media LLC

Subject

Safety, Risk, Reliability and Quality,Software

Reference60 articles.

1. AAMI. (2001). Medical device software-software life cycle processes, ANSI (American National Standard)/AAMI (Association for the Advancement of Medical Instrumentation) SW68:2001. http://www.techstreet.com/cgi-bin/detail?product_id=923487 .

2. AAMI. (2004). TIR32:2004, Medical device software risk management, http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/TIR320412%20preview.pdf .

3. AAMI. (2005). New guidance offered on software risk management. 40(2).

4. Automotive SIG. (2005). The SPICE User Group Automotive Special Interest Group, Automotive SPICE Process Reference Model, 2005, available from http://www.automotivespice.com .

5. Bassen, H., Silberberg, J., Houston, F., Knight, W., Christman, C., & Greberman, M. D. (1985). Computerized medical devices: Usage trends, problems and safety technology. In Proceedings of IEEE 7th annual conference engineering in medicine and biology society (pp. 180–185).

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