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Exploration on the regulation mode of medical device quality and safety on a life-circle basis / 中国医疗器械杂志
Hong-Liu YU; Xing-San QIAN.
Chinese Journal of Medical Instrumentation ; (6): 120-133, 2006.
Article in Zh | WPRIM | ID: wpr-355436
Responsible library: WPRO
ABSTRACT
A new conception of the life-circle state regulation for medical device's quality and safety is analyzed in the paper. The life-circle model and its corresponding regulation methods are discussed according to the characteristics of medical devices. Then, the regulation mode for application quality and safety of medical devices in a life-circle regulation system is explored.
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Full text: 1 Index: WPRIM Main subject: Product Surveillance, Postmarketing / Quality Control / Reference Standards / Safety Management / Device Approval / Government Regulation / Equipment and Supplies / Equipment Design / Equipment Safety / Methods Type of study: Prognostic_studies Limits: Humans Language: Zh Journal: Chinese Journal of Medical Instrumentation Year: 2006 Type: Article
Fulltext
Add to My VHL
Print
XML
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Full text: 1 Index: WPRIM Main subject: Product Surveillance, Postmarketing / Quality Control / Reference Standards / Safety Management / Device Approval / Government Regulation / Equipment and Supplies / Equipment Design / Equipment Safety / Methods Type of study: Prognostic_studies Limits: Humans Language: Zh Journal: Chinese Journal of Medical Instrumentation Year: 2006 Type: Article