Medical Device Compliance Crossword

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Across
  1. 5. New company entering the medical device market.
  2. 10. Consulting firm simplifying compliance.
  3. 12. Person Responsible for Regulatory Compliance.
  4. 13. Unique Device Identification.
  5. 14. Adhering to regulatory requirements.
  6. 17. Economic operator placing device on EU market.
  7. 19. Information attached to a medical device.
  8. 20. Official inspection of compliance.
Down
  1. 1. European database for medical devices.
  2. 2. Quality Management System.
  3. 3. U.S. authority regulating medical devices.
  4. 4. Instructions for Use.
  5. 6. Post-Market Surveillance.
  6. 7. European regulation for medical devices.
  7. 8. Evaluation or trial required for approval.
  8. 9. EU regulation for in-vitro diagnostic devices.
  9. 11. Marking that shows compliance in Europe.
  10. 15. International Organization for Standardization.
  11. 16. EU organization that verifies conformity.
  12. 18. Assessment required for device safety.