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Medical Devices Registration with US FDA

QSR820 - FDA Quality System Requirements

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QSR 820 is Quality System requirements of US FDA, applicable to medical devices defined by its requirement, used on human. It describes current code of manufacturing and quality control requirements. 

1.2 Quality System Requirements
1.3 Design Control
1.4 Document Control
1.5 Purchasing Control
1.6 Labeling and Trace-ability
1.7 Production and Process control
1.8 Acceptance action
1.9 unconformity
1.10 Corrective and preventive action
1.11 labeling and package control
1.12 Transport, storage, delivery and installation
1.13 Recording
1.14 Service
1.15 Statistic technology

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