Infosys Certified Medical Devices DotNet Professional
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Join Premium10 Infosys Certified Medical Devices DotNet Professional practice questions with answers
Real Lex exam-pattern multiple-choice questions for the Infosys Certified Medical Devices DotNet Professional certification. Each question includes the correct answer. The full question bank is available to Premium members.
- Question 1
State true/False. Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record), does not constitute "Medical Device Software"?
- ✓
true
Correct - B
false
- ✓
- Question 2
Activity that is carried out to validate the software product against the requirement specifications is called?
- ✓
Regression testing
Correct - B
System Testing
- C
Unit Testing
- D
Integration Testing
- ✓
- Question 3
State true/False. Software that are for keeping, Medical Records of patients, is not associated with "Medical Device Software"?
- ✓
true
Correct - B
false
- ✓
- Question 4
Which class of medical devices does not need premarket approval?
- ✓
Class I
Correct - B
Class II
- C
Class III
- D
Class I and II
- ✓
- Question 5
What is part numbering used for?
- ✓
Its purpose is to simplify referencing to the document.
Correct - B
Its purpose is to simplify PM and senior management's job.
- C
Its purpose is to encode the name of the document so that no one outside project can come to know about the document by looking at its name.
- D
All of the Choices
- ✓
- Question 6
The classification of medical devices in the European Union is outlined in Annex IX of the Council Directive ______?
- ✓
94/42/EEC
Correct - B
93/42/EEC
- C
None of the Choices
- ✓
- Question 7
FTA and FMEA are two tools that may facilitate the process of?
- ✓
Risk Control
Correct - B
Risk Analysis
- C
Both of the above
- D
None of the Choices
- ✓
- Question 8
Which one of the following is/are true? a. A 510(k) submission made to FDA, is applicable to Class I devices only. b. A 510(k) submission made to FDA, is applicable to Class I and Class II devices. c. Class III devices are approved by the Premarket Approval (PMA) process. d. If device is not being marketed or commercially distributed, 510(k) is not required.
- ✓
All are true.
Correct - B
All are False
- C
c and d are true.
- D
b, c and d are true.
- ✓
- Question 9
What should be the ideal retention period for project related artifacts?
- ✓
Life time of the product
Correct - B
As per contract
- C
Either of the Choices
- D
None of the Choices
- ✓
- Question 10
Which class of medical devices has the highest possibility of having insufficient information initially to assure safety and effectiveness?
- ✓
Class I
Correct - B
Class II
- C
Class III
- D
None of the Choices
- ✓
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