C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 820—QUALITY MANAGEMENT SYSTEM REGULATION › Subpart A—General Provisions

21 C.F.R. § 820.5

[Reserved]

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Notes of Decisions
Cited in 3 cases, 2005–2018 · leading case: Rowe v. Mentor Worldwide, LLC, 297 F. Supp. 3d 1288 (M.D. Fla. 2018).
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Rowe v. Mentor Worldwide, LLC, 297 F. Supp. 3d 1288 (M.D. Fla. 2018). “1 ; 21 C.F.R. § 820.5 ; 21 C.F.R. § 820.20 ; 21 C.”
Sekisui Am. Corp. v. Hart, 15 F. Supp. 3d 359 (S.D.N.Y. 2014). “21 C.F.R. § 820.5 . This system is known as the Quality Management System (“QMS").”
United States v. Utah Med. Prods., Inc., 404 F. Supp. 2d 1315 (D. Utah 2005). “21 C.F.R. 820.5 reads "[e]ach 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.”
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