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Are the current architectural practices suitable for safety aspects of medical devices? An exploratory investigation

 
: Leite, Fabio; Antonino, Pablo; Barbosa, Paulo; Kemmann, Sören; Mendonca, Raphael

:

IEEE Computer Society; Institute of Electrical and Electronics Engineers -IEEE-:
IEEE 16th International Conference on e-Health Networking, Applications and Services, Healthcom 2014. Proceedings : 15-18 October 2014, Natal, Brazil
Piscataway, NJ: IEEE, 2014
ISBN: 978-1-4799-6644-8
S.477-482
International Conference on e-Health Networking, Applications and Services (Healthcom) <16, 2014, Natal>
Englisch
Konferenzbeitrag
Fraunhofer IESE ()
medical device; safety; architecture evaluation; certification; NUTES

Abstract
We have investigated approaches in the literature to assess the quality of the software architectures of medical devices, and have found evidence that there is a lack of methodologies for evaluating the software architecture design aspects of medical devices that might affect system safety. Such evidences were identified when evaluating the software architecture of the FDA Generic Infusion Pump searching for architectural evaluation approaches available in the literature. In order to fill this gap, we propose a set of quality questions that focus on analyzing software architecture design aspects of medical devices aiming safety. We show arguments on why reference projects such as the FDA Generic Infusion Pump system must satisfy our new quality questions. The quality questions were integrated into a quality model commissioned by the Brazilian Health Ministery for the certification of medical devices.

: http://publica.fraunhofer.de/dokumente/N-330462.html