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Question 1

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 2

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 3

Brazilian device classification rules are similar to those of ______________.

Options :

A : Japan

B : USFDA

C : EU

D : China

Answer: C

Question 4

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 5

Which of the following result when analysis of the data sources detects the potential or an unfavourable trend that has not previously occurred.

Options :

A : Corrective actions

B : Corrections

C : Preventive actions

D : Corrections or corrective actions

Answer: C