Global Quality Week

12345678910111213141516
Across
  1. 2. Post-Market Surveillance (abbr.).
  2. 5. Title number of U.S. FDA regulation outlining quality system requirements for medical device manufacturers.
  3. 7. Device History Record (abbr.).
  4. 9. Ability to track the history of a device.
  5. 13. FDA Quality System Regulation (abbr.).
  6. 14. International standard for medical device quality management systems.
  7. 15. U.S. regulatory agency for medical devices (abbr.).
  8. 16. Information applied to device/packaging for identification and safe use.
Down
  1. 1. International standard for quality management systems focused on meeting customer and regulatory requirements.
  2. 3. Design History File (abbr.).
  3. 4. Systematic, documented evaluation of compliance.
  4. 5. Corrective Action and Preventive Action system (abbr.).
  5. 6. Unique Device Identifier (abbr.).
  6. 8. Show a process consistently produces expected results.
  7. 10. Potential for harm assessed and controlled under ISO 14971.
  8. 11. European conformity mark (2 letters).
  9. 12. Risk management standard for medical devices.
  10. 15. Failure Modes and Effects Analysis (abbr.).