Code of Federal Regulations (Last Updated: October 10, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 820 - Quality System Regulation |
Subpart A - General Provisions |
§ 820.5 - Quality system.
Latest version.
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§ 820.5 Quality system.
Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.