Question 1

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 2

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

Question 3

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 4

According to ISO 15223-1:2021, What does the below Medical Device Symbols for Labeling represent?

Options :

A : Importer

B : Distributor

C : Manufacturer

D : Biological risks

Answer: B

Question 5

According to ISO 19011:2018, Determining auditor competence should consider __________.

Options :

A : Personal behaviour

B : Generic knowledge and skills

C : Discipline and sector-specific competence

D : Personal behaviour, Generic knowledge and skills, and Discipline and sector-specific competence

Answer: D

Higher Test Marks with Free Online CMDA Exam Practice