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Title 21 - Title 21
Part 820 - QUALITY SYSTEM REGULATION
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Details about Part 820
Description
MEDICAL DEVICES - QUALITY SYSTEM REGULATION
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31 sections
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§820.1 - Scope.
Title 21, Part 820
§820.100 - Corrective and preventive action.
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§820.120 - Device labeling.
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§820.130 - Device packaging.
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§820.140 - Handling.
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§820.150 - Storage.
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§820.160 - Distribution.
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§820.170 - Installation.
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§820.180 - General requirements.
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§820.181 - Device master record.
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§820.184 - Device history record.
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§820.186 - Quality system record.
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§820.198 - Complaint files.
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§820.20 - Management responsibility.
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§820.200 - Servicing.
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§820.22 - Quality audit.
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§820.25 - Personnel.
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§820.250 - Statistical techniques.
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§820.3 - Definitions.
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§820.30 - Design controls.
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§820.40 - Document controls.
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§820.5 - Quality system.
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§820.50 - Purchasing controls.
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§820.60 - Identification.
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§820.65 - Traceability.
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§820.70 - Production and process controls.
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§820.72 - Inspection, measuring, and test equipment.
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§820.75 - Process validation.
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§820.80 - Receiving, in-process, and finished device acceptance.
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§820.86 - Acceptance status.
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§820.90 - Nonconforming product.
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