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Medical Device Regulatory下载

Medical Device Regulatory

Medical Device Regulatory

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Medical Device Regulatory 截图

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Medical Device Regulatory 描述

A valuable reference tool for medical device Regulatory Affairs (RA) and Quality Assurance (QA) professionals. Quick access to global medical device regulations, daily medical device regulatory updates, quick access to regulatory resources (videos, downloadable regulations, and more) for 24 countries. Also the full text of the US FDA QSR (Quality System Regulation, 21 CFR Part 820) and 10 other US regulations, plus full text of the European Medical Devices Directive (MDD 93/42/EEC), the IVD Directive (98/79/EC), and Directive 2007/47/EC. This app includes regulatory information covering 90% of the global medical device market including:
• Australia
• Brazil
• Canada
• China
• Europe
• Hong Kong
• India
• Japan
• Malaysia
• Mexico
• Russia
• South Korea
• Taiwan
• Turkey
• United States
一个有价值的参考工具,医疗器械监管事务(RA)和质量保证(QA)专业人员。快速进入全球医疗器械法规,日常医疗器械监管更新,快速进入监管资源(视频,可下载的法规,更多)的24个国家。另外,美国FDA QSR(质量体系法规,符合21 CFR Part 820)和10个其他美国法规,加上欧洲医疗器械指令(MDD 93/42 / EEC),体外诊断指令全文全文(98/79拥有欧盟/ EC),并指令2007/47 / EC。这个程序包括覆盖90%的全球医疗器械市场,包括监管信息:
•澳大利亚
•巴西
•加拿大
•中国
•欧洲
• 香港
•印度
•日本
•马来西亚
•墨西哥
•俄罗斯
•韩国
•台湾
• 火鸡
•美国

Medical Device Regulatory 更新内容

Update 27 August 2015 - now includes EU DIRECTIVE 2007/47/EC, updated USA FDA QSR (21 CFR Part 820) and other updated FDA regulations, updated versions of the Regulatory process charts. Regulatory Process charts now include Colombia, Malaysia, Taiwan and Turkey, and feature Timeline to Medical Device Approval for 20 countries.

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Medical Device Regulatory 信息

大小
10.27M
TAG
更新
版本
1.02
要求
Android 2.3.3 以上
查看权限要求
来自
Google Play

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