Quality and Regulatory Month Week 1

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Across
  1. 4. ____ device exemption
  2. 5. International Standards Organization
  3. 6. ___ Centric
  4. 7. ____ Evidence
  5. 9. Current Month
  6. 11. Built as ___ for my family
  7. 12. regulatory filing for PMA-S changes in one domain with no change to performance
Down
  1. 1. FDA regulates medical this element of a medical product
  2. 2. FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices
  3. 3. 510k files produce this
  4. 5. Foundation of Quality
  5. 8. CRMs notified body
  6. 10. regulatory filing of a process change with no change to performance