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Total 267 Questions | Updated On: Nov 19, 2024

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Question 1

If resterilization is indicated due to a process nonconformity, the effect of resterilization on the product and packaging should have been ______________.

A : Determined in the validation study to allow such reprocessing

B : Determined in the verification study to allow such reprocessing

C : Design master record (DMR)

D : Recorded on product label

Answer: A

Question 2

According to QSIT (Quality System Inspection Technique), ‘medical device reporting’ is a satellite subsystem of which subsystem?

A : Corrective and preventive action

B : Production and process controls

C : Material controls

D : Management controls

Answer: A

Question 3

If validation study was not conducted on resterilization, what is true?

A : The device can be resterilized and the same is recorded in Design master record

B : The device can be resterilized and the same is recorded in Device history record (DHR)

C : The device cannot be resterilized

D : The device can be resterilized and the same is recorded on product label

Answer: C

Question 4

ISO/IEC 17025 standard is applicable to _______________.

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

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

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

Page: 1 / 54

Total 267 Questions | Updated On: Nov 19, 2024

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