Software Risk Analysis in Medical Device Development

被引：1

作者：

Lindholm, Christin ^{[1
]}

Notander, Jesper Pedersen ^{[1
]}

Host, Martin ^{[1
]}

机构：

[1] Lund Univ, Fac Engn, Software Engn Res Grp, Dept Comp Sci, Lund, Sweden

来源：

2011 37TH EUROMICRO CONFERENCE ON SOFTWARE ENGINEERING AND ADVANCED APPLICATIONS (SEAA 2011) | 2011年

关键词：

risk management; risk analysis; software development; medical device development;

D O I：

10.1109/SEAA.2011.65

中图分类号：

TP31 [计算机软件];

学科分类号：

081202 ; 0835 ;

摘要：

The purpose of risk management in the development of safety-critical software is to eliminate or reduce harmful behaviour. In health-care it is essential to manage risk related to software due to its increased use in medical devices and other computer systems. This paper presents some of the experiences gained from an ongoing case study at a large hospital in Sweden. The study focuses on identification and analysis of risks using scenarios and how effective this approach is. The research is conducted as action research, with the aim of analysing and giving input to the organisation's new software risk management process.

引用

页码：362 / 365

页数：4

共 12 条

[1]

[Anonymous], DRUG COSM ACT SECT

[2]

[Anonymous], INT C SOFTW ENG ICSE

[3]

[Anonymous], IEEE COMPUTER

[4]

[Anonymous], IEEE INT C COMP SYST

[5] Software risk management [J].

Fairley, RE .

IEEE SOFTWARE, 2005, 22 (03) :101-101

[6]

Hall E., 1998, MANAGING RISK METHOD

[7]

Leveson N. G., 1995, Safeware: System Safety and Computers

[8] Risk management capability model for the development of medical device software [J].

Mc Caffery, Fergal ;

Burton, John ;

Richardson, Ita .

SOFTWARE QUALITY JOURNAL, 2010, 18 (01) :81-107

[9]

Robson C., 1993, REAL WORLD RES RESOU

[10] Guidelines for conducting and reporting case study research in software engineering [J].

Runeson, Per ;

Hoest, Martin .

EMPIRICAL SOFTWARE ENGINEERING, 2009, 14 (02) :131-164

← 1 2 →