
Medical Device
Professional Development
Professional Development
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10 questions
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1.
MULTIPLE CHOICE QUESTION
20 sec • 1 pt
Which of the below is totally new in clause 4?
Medical device file
Control of document
Control of Records
Quality manual
2.
MULTIPLE CHOICE QUESTION
20 sec • 1 pt
Which are the following not a part of the quality objective?
Relevant function and level
Regulatory requirements
Product requirements
Company requirements
3.
MULTIPLE CHOICE QUESTION
20 sec • 1 pt
What is the clause number for management review?
5.5
5.6
5.4
5.1
4.
MULTIPLE CHOICE QUESTION
20 sec • 1 pt
What is the title of clause 6.4?
Work environment
contamination control
Work environment and contamination control
Infrastructure
5.
MULTIPLE SELECT QUESTION
20 sec • 1 pt
What is the criteria for risk?
Meeting regulatory requirements
Usage of medical device
Safety of Medical Device
Performance of medical device
6.
MULTIPLE SELECT QUESTION
20 sec • 1 pt
Records shall be
Stored
photocopy
Retrieved
Retained
7.
MULTIPLE CHOICE QUESTION
20 sec • 1 pt
Which clause applicable to you?
7.5.3 installation activities
7.5.4 servicing activities
7.5.6 particular requirements for sterile medical devices
7.1 planning of product realization
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