21 C.F.R. § 820.5 Quality system.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 820—QUALITY SYSTEM REGULATION
Subpart A—General Provisions
§ 820.5 Quality system.