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Question 1 of 10
1. Question
A device that doesn’t meet specified requirements is referred to in a Quality System as:
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Question 2 of 10
2. Question
GMP stands for:
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Question 3 of 10
3. Question
The basic purpose of the system of corrective and preventive actions is to:
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Question 4 of 10
4. Question
A complaint file can address these issues:
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Question 5 of 10
5. Question
As referred to in a Quality System, data sources are used to:
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Question 6 of 10
6. Question
The systemic approach for identifying issues, analyzing data, and resolving problems is referred to as:
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Question 7 of 10
7. Question
The method used to determine why a failure existed is referred to as:
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Question 8 of 10
8. Question
When investigating root cause these factors can contribute to a complaint or non-conformance:
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Question 9 of 10
9. Question
If a medical device causes death or serious injury to a patient, FDA requires the manufacturer of the device to initiate:
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Question 10 of 10
10. Question
The document completed to begin a trend analysis is:
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