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Technical File - 技术文件 | Medcert

https://www.medcert-cn.com/technical-file

Download Center – 下载中心. Medcert Documents – Medcert文件. Standards and Legislation -标准与法规. Links – 外部链接. Index – 指数. Declaration of Conformity 符合性声明. Which Standards can be applied? Quality Management Systems 质量管理体系. The route to CE-Marking 取得CE 标志的途径. Class I Medical Devices (Conformity Assessment Procedure) 验证评估程序 I 级. Class I (steril or with measuring function) Medical Devices 验证评估程序 Is 级与Im级. Class IIa Medical Devices (Conformity Assessment Procedure) 验证评估程序 IIa 级. What is ISO 13485? Links – 外部链接.

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