Across
- 1. Documents the identification and disposition of material which does not meet specification
- 3. Improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations
- 7. 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 …...
- 9. Sales Rep who played football at the University of South Carolina
- 13. Is another term used to describe a FDA mandatory market withdraw
- 14. Trumpf Medical Systems Engineering R & D Center
- 15. The "D" in FDA stands for
- 16. 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.
- 17. FDA Pre-market clearance
- 19. 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).
- 20. 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
- 23. Process to ensure equipment limits for accuracy and precision
- 25. A process that uses objective evidence to confirm that specified requirements have been met
- 27. TUSM's appointed MWER, Management with Executive Responsibility
- 29. Played college basketball at Johns Hopkins University
- 32. TUSM's Notified Body responsible for auditing facility to the requirements of ISO 13485
- 34. DHF or _________History File is a collection of all relevant documents detailing the design of your device.
- 35. MRB or Material __________Board is responsible for determining the disposition of nonconforming material
Down
- 2. A manufacturer's declaration that the product meets the requirements of the applicable EC(European Countries) directives
- 4. The FDA Commissioner is appointed by the ________.
- 5. In November of 2014 TUSM had its first and only FDA ______.
- 6. 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.
- 8. A ________ Letter is given when FDA finds that a manufacturer has significantly violated FDA regulations.
- 10. Played for the Washington Redskins & Arizona Cardinals
- 11. A systematic, independent examination of a manufacturer's quality system that is performed at defined intervals
- 12. ISO 13485 is the ISO standard specific to _______ manufacturers
- 18. A person or an organization that provides products or services to another organization.
- 20. Board responsible for providing oversight and monitoring the CAPA Process.
- 21. Location of Trumpf Medical System's largest Manufacturing Site
- 22. TUSM's appointed Quality Management Representative
- 24. DHR or Device_______ Record is a compilation of records containing the production history of a finished device.
- 26. Quality ________ is the Quality Policy for Hill-Rom and Trumpf Medical.
- 27. Hill-Rom's Senior VP of Quality & Regulatory
- 28. Responsible for protecting the public health by assuring that medical devices intended for human use are safe and effective
- 30. 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.
- 31. The "F" in FDA stands for
- 33. FDA established barcoding device identification system to adequately identify medical devices through their distribution and use