Question 1

The term or period during which a commodity remains suitable for the intended use is called ________.

Options :

A : Intended use period

B : Usage life

C : Suitable life

D : Shelf life

Answer: D

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 can be the best suitable ‘severity’ rating to measure the possible consequences of hazard if the hazard can result in ‘patient death’? NOTE: Rating scale from highest to lowest: catastrophic, critical, serious, minor & negligible.

Options :

A : Serious

B : Minor

C : Catastrophic

D : Negligible

Answer: C

Question 4

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

Question 5

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

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