Question 1

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 2

If resterilization is indicated due to a process nonconformity, the effect of resterilization on the product and packaging should have been ______________.

Options :

A : Determined in the validation study to allow such reprocessing

B : Determined in the verification study to allow such reprocessing

C : Design master record (DMR)

D : Recorded on product label

Answer: A

Question 3

ISO/IEC 17025 standard is applicable to _______________.

Options :

A : First- & Second- party laboratories

B : First party laboratories

C : Second-, and Third- party laboratories

D : First-, Second-, and Third- party laboratories

Answer: D

Question 4

Which of the following audits are generally more in depth than the other audits?

Options :

A : Regulatory inspection

B : 3rd party audit

C : 1st party audit

D : 2nd party audit

Answer: C

Question 5

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

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