Across
- 2. Includes device malfunctions in the field.
- 3. Who is our authorized representative in the EU?
- 7. When an external agency reviews our QMS.
- 9. The VP of Regulatory/Quality.
- 11. Device used to inspect parts or to see tiny detail when product is being built
- 12. Electronic Quality Management System.
- 13. The regulatory body for medical devices in the USA.
- 14. How many hours does someone have to report a potential complaint to Vigilance?
- 15. How to make sure devices measure correctly.
Down
- 1. Name for when something doesn't meet specification requirements.
- 4. We ____ product that doesn't meet spec and can't be used.
- 5. Part of the IPG module (Robin’s friend).
- 6. Who is our Notified Body?
- 8. When someone (Dee) verifies components sent to us meet our requirements.
- 10. The symbol that shows compliance and approval for medical devices in Europe.
