Software development practice for FDA-compliant medical devices

Proceedings of the 2009 International Joint Conference on Computational Sciences and Optimization, CSO 2009

Volumn 2, Issue , 2009, Pages 388-390

  Lin, Weiguo ^a   Fan, Xiaomin ^b  

^a State Key Laboratory of Media Convergence and Communication   (China)

^b China Petroleum Material &   (China)

Author keywords

[No Author keywords available]

Indexed keywords

AGILE METHODS; DIGITAL SUBTRACTION ANGIOGRAPHY; HYBRID METHODOLOGIES; MEDICAL DEVICES; PROJECT RISK; REGULATORY ENVIRONMENT; SOFTWARE DEVELOPMENT; SOFTWARE DEVELOPMENT PRACTICES; SOFTWARE DEVELOPMENT PROCESS;

COMBINED SEWERS; COMPUTER SOFTWARE; REGULATORY COMPLIANCE; SOFTWARE DESIGN;

FORMAL METHODS;

EID: 70449450595     PISSN: None     EISSN: None     Source Type: Conference Proceeding    
DOI: 10.1109/CSO.2009.191     Document Type: Conference Paper

References (7)

1. US FDA/CDRH, 21CFR820, Quality System Regulation, 2007.
2. ISO 13485:2003, Medical devices - Quality management systems - Requirements for regulatory purposes. 2003.
3. US FDA/CDRH, Premarket Notification 510(k), 2006.
4. US FDA/CDRH, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005.
5. US FDA/CDRH, Design Control Guidance For Medical Device Manufactures, Mar.1997.
6. F. McCaffery, D. McFall, P. Donnelly , F.G. Wilkie, R. Sterritt, A Software Process Improvement Lifecycle Framework for the Medical Device Industry, Proceedings of the 12th IEEE International Conference and Workshops on the Engineering of Computer-Based Systems (ECBS'05), 2005.
7. Barry Boehm, Get Ready for Agile Methods with Care, Computer, Volume 35, Issue 1, January 2002.