RT Conference Proceedings
T1 Safety Case Driven Development for Medical Devices
A1 Ruiz, Alejandra
A1 Barbosa, Paulo
A1 Medeiros, Yang
A1 Espinoza, Huascar
A2 Koornneef, Floor
A2 van Gulijk, Coen
AB Medical devices are safety-critical systems that must comply with standards during their development process because of their intrinsic potential of producing harms. Although the existing trend of an increasing complexity of medical hardware and software components, very little has been done in order to apply more mature safety practices already present on other industrial scenarios. This paper proposes a methodology to enhance the Model-Based System Engineering (MBSE) state-of-art practices from the safety perspective, encouraging the use of safety cases and providing guidance on how to show the correspondent traceability for the development artifacts. We illustrate our methodology and its usage in the context of an industrial Automated External Defibrillator (AED). We suggest that medical device industry could learn from other domains and adapt its development to take into account the hazards and risks along the development, providing more sophisticated justification, as, for example, the impact of design decisions.
PB SPRINGER INT PUBLISHING AG, GEWERBESTRASSE 11, CHAM, CH-6330, SWITZERLAND
SN 978-3-319-24255-2; 978-3-319-24254-5
SN 9783319242545
YR 2015
FD 2015-11-25
LA eng
NO Ruiz , A , Barbosa , P , Medeiros , Y & Espinoza , H 2015 , Safety Case Driven Development for Medical Devices . in F Koornneef & C van Gulijk (eds) , unknown . 0302-9743 , SPRINGER INT PUBLISHING AG, GEWERBESTRASSE 11, CHAM, CH-6330, SWITZERLAND , pp. 183-196 , 34th International Conference on Computer Safety, Reliability, and Security, SAFECOMP 2015 , Delft , Netherlands , 23/09/15 . https://doi.org/10.1007/978-3-319-24255-2_14
NO conference
NO Publisher Copyright: © Springer International Publishing Switzerland 2015.
DS TECNALIA Publications
RD 3 jul 2024