Question 1

Which type of inspection generally performed when regulatory authorities perceive a public threat, detect or suspect any fraudulent activity, counterfeit products?

Options :

A : Pre-market product approval

B : Internal audit

C : Routine regulatory inspection

D : For-cause inspection

Answer: D

Question 2

According to 21 CFR 830, generally the UDI rule requires a UDI of a device on ______________.

Options :

A : Device label and package

B : Device package

C : Device itself as a permanent UDI

D : Device label

Answer: A

Question 3

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 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

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

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