21 CFR 820.5 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Quality System Regulation (§ 820.1 To § 820.250) — General Provisions (§ 820.1 To § 820.5) — Quality system.

4 Aug 2016

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.

21 CFR 820.5