内容提示: ~ - 1 - ~[Code of Federal Regulations][联联邦邦法法规规][Title 21, Volume 8][ 标题 21 ,第 8 卷][CITE: 21 CFR 820][ 引用:21 CFR 820]TITLE 21--FOOD AND DRUGS标题 标题21--食品和药品 食品和药品CHAPTER I--FOOD AND DRUG ADMINISTR第 第I 章--食品和药品管理局 食品和药品...
美国FDA-21CFR820法规(详细)英文版 SUBCHAPTER H--MEDICAL DEVICES PART 820 QUALITY SYSTEM REGULATION Subpart A--General Provisions § 820.1 - Scope. § 820.3 - Definitions. § 820.5 - Quality system. Subpart B--Quality System Requirements § 820.20 - Management responsibility. § 820.22 - Quality...
Provides the text of U.S. FDA 21 CFR Part 820 as an example of configuration management in a regulatory environment
CFR全称是Code of Federal Regulations。21CFR是美国联邦法规第21条，有关食品、药品、医疗器械、辐射类...
In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements. (c)Authority. Part 820 is established and issued under authority ...
QSR820,又称21CFR820,是美国医疗器械质量管理体系法规的英文缩写,因其位于美国联邦法规(Code of Federal Regulations)第21卷第820部分,故名。QSR820是美国(人用)医疗器械制造商以及拟将产品销往美国的外国(人用)医疗器械制造商必须遵守的质量管理体系法规。是多数医疗器械在美国上市之前必须遵守、上市之后随时可能抽查的...
conflict between applicable regulations in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements. (c)Authority. Part 820 is established and issued under authority of sections 501, ...
概述:美国《联邦规章典集》(Code of Federal Regulations,CFR)第21篇“食品与药品”(Title 21―Food and Drugs)共有9卷(Volume)、3章(Chapter)、1499部(Parts)。其中:第1―8卷第1章第1―1299部,为健康与人类服务部食品与药品管理局(Food and Drug Administration,Department of Health and Human Services)的...
21 CFR 167; 820Quality System Regulation质量体系手册Subpart AGeneral ProvisionsA部分总则820.1 Scope.范围820.3 Definitions. 定义820.5 Q
21 CFR 167; 820Quality System Regulati on质量体系手册Subpart A Gen eral Provisi onsA局部一一总那么820.1 Scope.820.1 围820.3 Defi nitio