A software process improvement lifecycle framework for the medical device industry

Proceedings - 12th IEEE International Conference and Workshops on the Engineering of Computer-Based Systems, ECS 2005

Volumn , Issue , 2005, Pages 273-280

  McCaffery, F ^a   McFall, D ^a   Donnelly, P ^b   Wilkie, F G ^a   Sterritt, R ^a  

^a Centre for Software Process Technologies   (United Kingdom)

^b IQ Solutions   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL EQUIPMENT; INTEGRATION; PROCESS CONTROL;

MEDICAL DEVICE INDUSTRY; SOFTWARE FRAMEWORK; SOFTWARE PROCESS IMPROVEMENT (SPI); SOFTWARE PROCESSES;

SOFTWARE ENGINEERING;

EID: 28344452003     PISSN: None     EISSN: None     Source Type: Conference Proceeding    
DOI: None     Document Type: Conference Paper

References (11)

1. FDA Regulations. "Code of Federal Regulations 21 CFR Part 820." June 1997.
2. European Council, "Council Directive 93/42/EEC Concerning Medical Devices", 14 June 1993.
3. Safety in the Process Industries - Guiding Principles to the implementation of IEC 61508 www.sipi61508.com
4. ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes. www.iso.ch
5. McFall, D., Wilkie, F.G. McCaffery, F. Lester, N.G. and Sterritt, R. "Software Processes and Process Improvement in Northern Ireland", 16th International Conference on Software & Systems Engineering and their Applications, Paris, France, December 2003, ISSN: 1637-5033, p1-10.
6. The Centre for Software Process Technologies, University of Ulster, www.cspt.ulster.ac.uk.
7. Ju Dehua., China's Budding Software Industry, IEEE Software May/June 2001. pp 92-95
8. SM) for Software Engineering (CMMI-SW, V1.1, Version 1.1, August 2002)
9. FDA/CDRH Guidance Document. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." May 1998.
10. FDA/CDRH Guidance Document. "Guidance for Off-the-Shell Software Use in Medical Devices." September 1999
11. FDA/CDRH Guidance Document. "General Principles of Software Validation." June 1997.