文章基本信息
- 标题：Ensuring safety and efficacy of medical devices
- 本地全文：下载
- 作者：Alfred M Dolan
- 期刊名称：ISO Focus
- 出版年度：2009
- 卷号：2009
- 期号：jun
- 出版社：International Organization for Standardization
- 摘要：International Standard ISO 14971:2007, Medical devices – Application of risk management to medical devices, is the definitive worldwide standard for the medical device sector. It is first and foremost a management standard, covering the entire life cycle of all types of medical devices.
