Free CMDA Exam Questions - Easiest Way for Success

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Total 267 Questions | Updated On: Sep 11, 2024

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Question 1

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

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 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

Which of the following control charts is used to trend continuous data?

A : X-bar chart

B : U chart

C : np chart

D : P chart

Answer: A

Question 5

The audit report should be issued within ____________ .

A : 60 days from audit closing date

B : An agreed period of time

C : 30 months from audit closing date

D : 30 days from audit closing date

Answer: B

Page: 1 / 54

Total 267 Questions | Updated On: Sep 11, 2024

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