FDA-21 CFR Part 820新版医疗器械质量管理体系法规(QMSR)征求意见稿(中文)-202202.pdf,第 820 部分——质量管理体系法规QMSR A 分部——一般规定 820.1 范围。 820.3 定义。 820.5 [预留的] 820.7 通过引用并入。 820.10 质量管理体系的要求。 820.15 澄清概念。 B ——分
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
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 ...
美国联邦公告Federal Register 于2022年2月23日发布:FDA提议修订21 CFR Part 820医疗器械质量体系法规QSR(Quality System Regulation),使其要求与国际上普遍共识的医疗器械质量管理体系标准ISO13485:2016版的要求更加趋于一致。修订后的法规将被称为QMSR (Quality Management System Regulation)。
21 CFR Part 820 Quality System Regulation 21 CFR Part 803 Medical Device Reporting 21 CFR Part 806 Medical Devices; Reports Of Corrections And Removals 21 CFR Part 821 Medical Device Tracking Requirements(仅限于植入超过1年的器械、生命支持器械,或器械失效时可造成严重不良后果的器械) ...
Subpart A--General Provisions Sec.820.1Scope.(a)Applicability.(1)Current good manufacturing practice(CGMP)requirements are set forth in this quality system regulation.The requirements in this part govern the methods used in,and the facilities and controls used for,the design, manufacture,packaging,...
美国FDA-21CFR820法规培训教学PPT课件 热度: 相关推荐 SUBCHAPTERH--MEDICALDEVICES PART820QUALITYSYSTEMREGULATION SubpartA--GeneralProvisions §820.1-Scope. §820.3-Definitions. §820.5-Qualitysystem. SubpartB--QualitySystemRequirements §820.20-Managementresponsibility. §820.22-Qualityaudit. §820.25-Personne...
Easily meet QSR requirements, improve efficiency and keep compliance costs down. Download Your Free 21 CFR Part 820 Q&A Document MasterControl Product QMS Software Learn More MasterControl Solutions Manufacturing Software Solutions Learn More MasterControl Product ...
820 质量体系规章 QUALITY SYSTEM REGULATION 821 医疗器械跟踪要求 MEDICAL DEVICE TRACKING REQUIREMENTS 822 上市后监视 POSTMARKET SURVEILLANCE 860 医疗器械分类程序 MEDICAL DEVICE CLASSIFICATION PROCEDURES 861 性能标准制定程序 PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT 862 临床化学与临床毒理学器械 CLINICAL ...