A device master record (DMR) is a collection of records that contains the procedures and specifications for a finished medical device. According to the FDA quality system regulation, a device master record should include, or refer to the location various
Device Master Recorddoi:DOXPUB 09-0007-SOP概述:介绍设备主记录(DMR)的使用和维护.旨在确保设备文件的产品配置控制,如设计,配方,规格,完整的制造程序,质量控制要求和最终产品标签.涵盖DMR索引内容,索引编制,更新和审查索引,以及DMR的发布和访问控制.包括符合MDD 93/42/EEC附录V和21 CFR第820.181部分的规定.包括的...
[translate] ait ain't wrking u add Robert15a 它不wrking u增加Robert15a [translate] aDevice Master Record 设备主记录 [translate] 英语翻译 日语翻译 韩语翻译 德语翻译 法语翻译 俄语翻译 阿拉伯语翻译 西班牙语翻译 葡萄牙语翻译 意大利语翻译 荷兰语翻译 瑞典语翻译 希腊语翻译 51La ...
Device master record 选择语言:从中文简体中文翻译英语日语韩语俄语德语法语阿拉伯文西班牙语葡萄牙语意大利语荷兰语瑞典语希腊语捷克语丹麦语匈牙利语希伯来语波斯语挪威语乌尔都语罗马尼亚语土耳其语波兰语到中文简体中文翻译英语日语韩语俄语德语法语阿拉伯文西班牙语葡萄牙语意大利语荷兰语瑞典语希腊语捷克语丹麦语匈牙利语...
The definition for Design Output 820.3(g) and requirements for Design Output 820.30(d) do not apply to most Class I devices. Therefore, the requirements for the DMR for most Class I devices are in 820.181 Device Master Record. Of course, a manufacturer of Class I devices may use the ...
Device Master Record HomeFeaturesDevice Master Record Good Manufacturing Practices require that you have a Device Master Record for each unique formulation and each unique batch size. This ensures that all proper ingredients are added, that each process step is completed according to an established ...
Временнопринялосамуюважнуюхарактеристикутакжерешалопосленесколькиххарактерноесуществование.[translate] aDevice master record 设备主人记录[translate]...
网络器械主文档;器械主记录 网络释义 1. 器械主文档 ...检查文件•质量手册•程序文件•支持文件(SOP)•器械主文档(Device Master Record)•外来标准(包括FDA法规)注意:加入21CFR … doc.mbalib.com|基于 1 个网页 2. 器械主记录 FDA医疗器械质量体系手册... ... 7. Equipment and Calibration7. ...
Device Master Record Management Benefits TheDevice Master Record (DMR)is a regulatory requirement forMedical Deviceproduct development. In short, a DMR contains all the information needed to manufacture your product. This includes, but is not limited to: ...
device.Thedetailedrequirementsfordevicemasterrecordsarecontainedinsection820.181,aswellasthroughouttheregulation.Thedefinitionfordesignoutputin820.3(g)givesthebasisand/ororiginofthedevicemasterrecordforallClassIIandIIIdevicesasfollows:Designoutputmeanstheresultsofadesigneffortateachdesignphaseandattheendofthetotaldesign...