Design Control Quiz - Vee Care Asia

Design Control Quiz

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

a) True

b) False

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

a) True

b) False

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

a) True

b) False

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

a) True

b) False

5. Regulatory requirement is a source of design input.

a) True

b) False

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

a) True

b) False

7. Clinical Study is a type of product validation.

a) True

b) False

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

a) True

b) False

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

a) True

b) False

10. Design control process starts with project proposal.

a) True

b) False

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

a) Set quality practices and procedures

b) Assure the device meets user needs and intended uses

c) Meet regulatory requirements

d) All of the above

e) None of the above

2. The design control shall be conducted when

a) New product development

b) New intended uses

c) New components

d) A & B

e) None of the above

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

a) User Needs > Design Input > Design Output > Design Validation > Design Verification > Design Transfer

b) User Needs > Design Input > Design Output > Design Verification > Design Validation > Design Transfer

c) User Needs > Design Input > Design Validation > Design Output > Design Verification > Design Transfer

d) User Needs > Design Input > Design Transfer > Design Output > Design Validation > Design Verification

e) User Needs > Design Input > Design Output >Design transfer > Design Validation > Design Verification

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

a) Financial Manager

b) Sales Manager

c) R&D Manager

d) Production Manager

e) Quality Manager

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

a) Effective product

b) Stable Product

c) Ease of use

d) Product Composition

e) Safe product

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

a) Medial Indications

b) Device Materials

c) Intended Users

d) Duration of Use

e) Single Use / Multiple Use

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

a) Product Complaints

b) Service Reports

c) Competitor products

d) CAPA

e) Customers’ Feedback

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

a) Patients

b) Radiographer

c) Pharmacist

d) Nurse

e) General Physician

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

a) Syringe Dimension

b) Syringe Label

c) Sterile package

d) All of the above

e) None of the above

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

a) meet the input requirements for design and development

b) provide appropriate information for purchasing, production, and for service provision

c) specify the essential tests required to verify product performance

d) contain or reference product acceptance criteria, and

e) specify the characteristics of the product that are essential for its safe and proper use

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

a) Clinical Study

b) Electrical Safety Test Report

c) Biocompatibility Report

d) Device Performance Test Report

e) None of the above

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

a) Labelling changes

b) Engineering changes

c) Distributor changes

d) Material changes

e) None of the above

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

a) Update technical file

b) Update design history control

c) Notify notified body

d) Risk assessment of changes

e) None of the above

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

a) 1

b) 2

c) 3

d) 4

e) 5

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

a) Diagnosis of Hypertension

b) Measurement of Blood Pressure

c) Control of Hypertension

d) Monitoring Hypertension

e) Management of pharmacological treatment

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

a) Competitor Product

b) Device Performance Test

c) Device Clinical Study

d) Device Safety Test

e) All of the above

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

a) Compliance to IEC 60601-1 Electrical Safety

b) Compliance to ISO 10993 Biocompatibility

c) Device Dimension

d) Device Instruction Manual

e) All of the above

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

a) Laboratory Testing

b) Clinical Testing

c) Customer Survey

d) Risk Analysis

e) All of the above

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

a) Biocompatibility Test

b) Focus Group

c) Expert Opinion

d) Clinical Study

e) All of the above

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

a) Change of distributor

b) Change of suppliers’ sales agent

c) Change of device enclosure

d) Change of production personnel

e) All of the above

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