A validation model for the medical devices industry

Journal of Engineering Design

Volumn 13, Issue 3, 2002, Pages 197-204

  Alexander, Karen ^a   Clarkson, P John ^a  

^a UNIVERSITY OF CAMBRIDGE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

MEDICAL DEVICES;

CONSTRAINT THEORY; ECONOMICS; ENGINEERING RESEARCH; MATHEMATICAL MODELS; PRODUCTION; ROBUSTNESS (CONTROL SYSTEMS);

BIOMEDICAL EQUIPMENT;

EID: 0036753823     PISSN: 09544828     EISSN: None     Source Type: Journal    
DOI: 10.1080/09544820110108890     Document Type: Article

References (6)

1. Alexander, K., 1999, Design for validation of medial devices and equipment, Ph.D. Thesis, Department of Engineering, University of Cambridge, UK.
2. Clarkson, P.J., Alexander, K. and Bishop, D., 1999, Observations on medical device design, Part I: current practice, Medical Device Technology, 10(7), pp. 28-31.
3. DeMarco, T., 1982, Controlling Software Projects: Management, Measurement & Estimation (Englewood Cliffs, NJ: Prentice-Hall).
4. Institution of Electrical Engineers, 1990, Guidelines for the Documentation of Computer Software for Real-Time and Interactive Systems, 2nd edn (London: Institution of Electrical Engineers).
5. Shefelbine, S., Clarkson, P.J. and Alexander, K., 1999, Requirements capture for medical devices, Workbook, Department of Engineering, University of Cambridge, UK.
6. Wiklund, M.E., 1995, Medical Device and Equipment Design: Usability Engineering and Economics (Buffalo Grove, IL: Interpharm Press).