Quality Matters

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Across
  1. 2. TUSM's appointed MWER, Management with Executive Responsibility
  2. 6. FDA established barcoding device identification system to adequately identify medical devices through their distribution and use
  3. 11. Sales Rep who played football at the University of South Carolina
  4. 13. The FDA began with the passage of the 1906 Pure Food and Drugs Act. This law was in direct response to the public outrage at the shockingly unhygienic conditions in the Chicago stockyards that were described in Upton Sinclair’s book …...
  5. 14. DHF, all relevant documents detailing the design of your device
  6. 16. Hill-Rom's Senior VP of Quality & Regulatory
  7. 18. Improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations
  8. 22. Location of Trumpf Medical System's largest Manufacturing Site
  9. 26. ISO 13485 is the ISO standard specific to _______ manufacturers
  10. 28. A systematic, independent examination of a manufacturer's quality system that is performed at defined intervals
  11. 29. TUSM's Notified Body responsible for auditing facility to the requirements of ISO 13485
  12. 31. When FDA finds that a manufacturer has significantly violated FDA regulations, it notifies the manufacturer via a …….
  13. 33. DHR, a compilation of records containing the production history of a finished device
  14. 35. the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment.
  15. 36. any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution
Down
  1. 1. The "D" in FDA stands for
  2. 3. Process to ensure equipment limits for accuracy and precision
  3. 4. GMP - refers to the "Good ____________Practices" for quality system requirements of medical device (and other) companies outlined by the US FDA in 21 CFR Part 820. Also referred to as the Quality System Regulation (QSR).
  4. 5. A person or an organization that provides products or services to another organization.
  5. 7. Played for the Washington Redskins & Arizona Cardinals
  6. 8. The "F" in FDA stands for
  7. 9. Board responsible for providing oversight and monitoring the CAPA Process.
  8. 10. MRB, responsible for determining the disposition of nonconforming material
  9. 11. The FDA Commissioner is appointed by the ________.
  10. 12. Quality Policy for Hill-Rom and Trumpf Medical
  11. 15. Responsible for protecting the public health by assuring that medical devices intended for human use are safe and effective
  12. 17. Is another term used to describe a FDA mandatory market withdraw
  13. 19. In November of 2014 TUSM had its first and only FDA ______.
  14. 20. GDP or "good __________ practice" is a term used in the medical device industry to describe standards by which documents are created and maintained. Often used to reference entering data or making corrections to a controlled record.
  15. 21. Documents the identification and disposition of material which does not meet specification
  16. 23. FDA Pre-market clearance
  17. 24. Integrated Table Motion enables what to connect to Trumpf Medical‘s TruSystem® 7000dV OR Table so that a patient can be dynamically positioned while the surgeon operates.
  18. 25. TUSM's appointed Quality Management Representative
  19. 27. Trumpf Medical Systems Engineering R & D Center
  20. 30. A process that uses objective evidence to confirm that specified requirements have been met
  21. 32. Played college basketball at Johns Hopkins University
  22. 34. A manufacturer's declaration that the product meets the requirements of the applicable EC(European Countries) directives