A survey of software engineering techniques in medical device development

Proceedings - 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability, HCMDSS/MDPnP 2007

Volumn , Issue , 2007, Pages 46-54

  Feldmans, Raimund L ^a   Shull, Forrest ^a   Denger, Christian ^b   Höst, Martin ^c   Lindholm, Christin ^c  

^a Fraunhofer USA Inc   (United States)

^b FRAUNHOFER IESE   (Germany)

^c LUND UNIVERSITY   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ENGINEERING; INTEROPERABILITY; SOFTWARE ENGINEERING; SURVEYS; SYSTEMS ENGINEERING; TECHNICAL PRESENTATIONS;

CURRENT STATUSES; DO-MAINS; ENGINEERING TECHNIQUES; FUTURE DIRECTIONS; INTEGRATED SOFTWARE SOLUTIONS; MEDICAL DEVICE INDUSTRIES; MEDICAL DEVICE MANUFACTURERS; MEDICAL DEVICES; RESEARCH AREAS; RESEARCH IDEAS; SOFTWARE ENGINEERS; SYSTEM ENGINEERINGS;

ENGINEERING RESEARCH;

EID: 48349106227     PISSN: None     EISSN: None     Source Type: Conference Proceeding    
DOI: 10.1109/HCMDSS-MDPnP.2007.4     Document Type: Conference Paper

References (13)

1. Future Trends in Medical Device Innovation. Advanced Medical Technologie Association (AdvaMed), 2004, http://advamed.org
2. ITEA 2 Blue Book. September 2005, www.iteaoffice.org
3. Wirtschaftsfaktor Gesundheit: Chancen und Potentziale für Deutschland. BDI-Initiative Vitale Gesellschaft, Bundesverband der Deutschen Industrie, 2005, http://www.vitalegesellschaft.de
4. Studie zur Situation der Medizintechnik in Deutschland im internationalen Vergleich. Bundesministerium für Bildung und Forschung, http://www.binbf.de
5. Dolores R. Wallace and D. Richard Kuhn: Failure Modes in Medical Device Software: An analysis of 15 years of recall data. International Journal of Reliability, Quality and Safety.
6. Bundesinstituts für Arzneimittel und Medizinprodukte, 2006, http://www.bfarm.de
7. ISO 14971:2000(E): Medical Devices - Application of risk management to medical devices. Genf, 2000.
8. IEC 60601-1-4, Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems. Ed. 1.1, 2000.
9. CDRH, General Principles of Software Validation; Final Guidance for Industry and FDA Staff. 2002, (see also http://www.fda.gov/cdrh/comp/guidance/ 938.html
10. Fault Trees And Reliability Block Diagrams. http://www.weibull.com/ basics/fault-tree/index.htm
11. Glenn D Krasker: Failure Modes And Effects Analysis: Building Safety into Everyday Practice. HC Pro, Inc., 2004.
12. The HAZOP (Hazard and Operability) Method. http://www.acusafe.com/ Hazard_Analysis/HAZOP_Te chnique.pdf
13. Erik Kamsties: Surfacing Ambiguity in Natural Language Requirements. PhD Thesis in Experimental Software Engineering, University of Kaiserslautern, Kaiserslautern, Germany. Published in 2001 by Fraunhofer IRB Verlag, Stuttgart, Germany, ISBN 3-8167-5903-3.