Question 1

Which of the following is an auditor should NOT do for both internet correspondence and for translations from English to another language?

Options :

A : Maintain consistency of terminology

B : Use complex or compound sentence

C : Stick to logical sequence of events

D : Avoid words that have multiple meanings

Answer: B

Question 2

Which of the following is not a terminal sterilization process?

Options :

A : Moist heat sterilization processing

B : Ethylene Oxide sterilization processing

C : Aseptic processing

Answer: C

Question 3

Which of the following are the two primary documents governing medical device softwares?

Options :

A : ISO 11607-1

B : ISO 10993-1

C : ANSI/AAMI/IEC 62304:2006 and FDA guidance General Principles of Software Validation

D : AAMI TIR22

Answer: C

Question 4

Employees working in the controlled environment should be properly trained on ___________.

Options :

A : Gowning procedures

B : Requirements for attire and behavior

C : Gowning procedures, requirements for attire and behavior

D : Gowning procedures and requirements for attire

Answer: C

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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