CrossWord Puzzle

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Across
  1. 1. A formal examination or review of processes, documentation, or products to ensure compliance with quality standards.
  2. 3. A medical device classification based on the degree of risk posed to patients.
  3. 4. A system of practices, procedures, and policies for ensuring products consistently meet requirements (Abbr.).
  4. 5. The U.S. agency responsible for regulating medical devices.
  5. 9. An activity to improve a product or process based on nonconformity or failure.
Down
  1. 2. The process of determining whether a product meets defined requirements.
  2. 3. The process of recording, analyzing, and resolving issues with a product that does not conform to specified requirements.
  3. 6. An international standard for medical device quality management systems (ISO _______).
  4. 7. A crucial document that outlines the requirements for a medical device's performance and safety (Abbr.).
  5. 8. A written instruction that ensures processes are followed correctly, often abbreviated as SOP.