Questions and Answers
Which of the following is NOT a requirement for labeling and packaging control?
Releasing labels without inspection
What should be done with nonconforming products?
Evaluate and segregate them
What is the purpose of Corrective and Preventive Action (CAPA)?
To fix problems and prevent their recurrence
Which of the following is NOT required for maintaining complaint files according to FDA regulations?
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Which of the following is NOT included in the Device Master Record (DMR) for each device?
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What is the purpose of establishing and maintaining procedures for statistical techniques in a quality system?
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What is the significance of the new regulations implemented in Europe for medical devices?
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