Across
- 1. Regulatory Authority for Medical Devices in New Zealand
- 4. A person or entity who designs, develops, assembles, or processes a finished device
- 5. ____ Study. Conducted to determine the shelf life of a product
- 10. inspection of processes and records to determine compliance to requirements
- 13. pRE=Potential ____ Event
- 14. Issued in the report for instances of non-conformance detected during an audit
- 15. Dossier of technical information submitted to the regulator for pre-market approval
- 16. Removal of product from the market after sale
Down
- 2. Non-conforming or returned products must be ____
- 3. Corrective and Preventative Action
- 6. Required before completing a task
- 7. ____ Material is used to directly promote products, services and or software.
- 8. Who you must contact before engaging with a new supplier?
- 9. Controlled site where products are stored prior to their distribution
- 11. Required to import or export certain materials
- 12. Regulatory Authority for medical devices in Australia