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- 医疗器械产品设计开发过程的控制Design control《医疗器械生产质量管理规范》 于2018 年1月1 日起全面施行， 对医疗器械产品质量控制过程提出了高要求，质量控制的核心是从源头有效减少产品缺陷或...2018-04-10 21:24:07
- FDA对于设计控制(Design Control)的要求与解析的帮助中小企业理解并实践21CFR 820.30章节中关于设计控制（Design Control）的规定，FDA发布了关于设计控制的培训。本文梳理了...2017-08-03 23:26:43
- Medical device supplier audit checklistat activities associated with the Design, material procurement, fabricatio...2024-09-19 17:27:12
- The Advantages of Using a Professional China Sourc... to get involved in prototype and Design, so this could scare them away to...2024-09-19 13:51:41
- Sourcing medical device in Chinar product specifications (color & Design, weight, dimensions, raw material...2024-09-19 13:40:58
- How to make sure your Chinese suppliers meet FDA r...current product sales. A properly Designed and managed supplier performanc...2024-09-19 13:36:03
- 全球医疗器械注册知识最全汇总的相关规定 (Criteria to be met for the Designation of notified bodies)附录Ⅻ、EC标志的...2019-03-17 22:03:39
- DHF内容要求SO13485 的要求，新设计的产品必需建立产品开发设计档案DHF（Design History File）, 那么DHF里面应该要包含什么样的内容...2018-03-16 12:56:50
- CFDA Good Manufacturing Practice for Medical Devi...uirements set out in the GMP when Designing and developing,manufacturing a...2018-02-08 09:21:45
- Medical Device CFDA Registration & Approvalormer SFDA). Foreign firms should Designate local legal agent and service ...2018-01-15 11:25:39