Title :
Overview of quality assurance for medical devices
Author_Institution :
Dept. of Electr. & Comput. Eng., North Carolina State Univ., Raleigh, NC, USA
Abstract :
Medical devices can have very stringent performance requirements. The life of a critically ill patient can be determined by the quality of the monitoring and therapeutic devices being used in his or her treatment. But how is quality guaranteed? What are the characteristics of a medical device that determine its quality? The author discusses the methods used for designing quality into medical devices
Keywords :
biomedical engineering; biomedical equipment; reliability; device development cycle; fault-tolerance; medical devices; performance requirements; quality assurance; reliability; Biomedical engineering; Biomedical monitoring; Computerized monitoring; Costs; Manufacturing; Patient monitoring; Product development; Product safety; Quality assurance; Testing;
Conference_Titel :
Biomedical Engineering Days, 1992., Proceedings of the 1992 International
Conference_Location :
Istanbul
Print_ISBN :
0-7803-0743-7
DOI :
10.1109/IBED.1992.247093
