1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 820 - QUALITY SYSTEM REGULATION
  6. Subpart A - General Provisions
  7. 21 CFR § 820.5
21 CFR § 820.5
Quality system
June 25, 2020
CFR

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.

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§ 820.3 Definitions

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