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Design Control Quiz

1. Design process is to ensure the device meets the intended uses of the device.

2. Manufacturer does not need to go through the design process for a change in pack insert

3. Design validation is a process used to determine whether the manufacturer makes the product correctly

4. Product complaint is not a source of design input.

5. Regulatory requirement is a source of design input.

6. The total finished design output consists of the device, its packaging and labeling, and the device master record.

7. Clinical Study is a type of product validation.

8. Design transfer is a process used to determine whether the manufacturer could produce the product in a correct manner.

9. Salespeople are not part of the design control team since they are not involved in product design.

10. Design control process starts with project proposal.

1. The purpose(s) of design control is/are to

2. The design control shall be conducted when

3. Which of the following is the correct sequence of a product design process?

4. Which of the following is NOT a member of the design control team?

5. Which of the following is NOT a user need?

6. Which of the following is NOT an element of intended use checklist?

7. Which of the following is the source of design input for a newly developed product?

8. What is the intended user of an X-ray machine?

9. Which of the following is the design output of a sterile hypodermic syringe?

10. Which of the following is NOT true for design output?

11. Which of the following is NOT design verification evidence?

12. Which of the following is NOT regarded a design change?

13. Which of the following is NOT a design change control?

14. What is the normal number of production run for a design transfer?

15. Which of the following is the intended use of a consumer blood pressure meter?

16. Which of the following is a design input source of a consumer blood pressure meter?

17. Which of the following is a design output of a consumer blood pressure meter?

18. Which of the following is a design verification method for a consumer blood pressure meter?

19. Which of the following is a design validation output of a consumer blood pressure meter?

20. Which of the following is regarded as a design change for a consumer blood pressure meter?

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