Question 1

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 2

Brazilian device classification rules are similar to those of ______________.

Options :

A : Japan

B : USFDA

C : EU

D : China

Answer: C

Question 3

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

Question 4

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 5

According to EU MDR 2017/745, what is the meaning of the requirement to reduce risks ‘as far as possible’?

Options :

A : The reduction of risks as far as possible without considering the benefit-risk ratio

B : The reduction of risks as far as possible even with adversely affecting the benefit-risk ratio

C : The reduction of risks as far as possible without adversely affecting the benefit-risk ratio

D : The reduction of risks as far as possible without considering regulatory compliance risk

Answer: C

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