Question 1

If validation study was not conducted on resterilization, what is true?

Options :

A : The device can be resterilized and the same is recorded in Design master record

B : The device can be resterilized and the same is recorded in Device history record (DHR)

C : The device cannot be resterilized

D : The device can be resterilized and the same is recorded on product label

Answer: C

Question 2

Which of the following is useful to graphically summarize and display the relative importance of the differences between groups of data?

Options :

A : Flowchart

B : Cause and effect diagram

C : Pareto chart

D : Scatter diagram

Answer: C

Question 3

What is the critical first step in the risk management process?

Options :

A : Risk analysis

B : Risk control

C : Risk evaluation

D : Risk management review

Answer: A

Question 4

According to the FD&C Act, if a device is characterized as being life sustaining, what should be classification of this device?

Options :

A : Class I

B : Class IIa

C : Class III

D : Class II

Answer: C

Question 5

Which of the following control charts is used to trend continuous data?

Options :

A : X-bar chart

B : U chart

C : np chart

D : P chart

Answer: A

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