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Questions and Answers
Which of the following is NOT a requirement for labeling and packaging control?
Which of the following is NOT a requirement for labeling and packaging control?
- Designing and constructing packaging to protect the device
- Ensuring labels remain legible and affixed during processing
- Establishing procedures for handling, storage, and distribution
- Releasing labels without inspection (correct)
What should be done with nonconforming products?
What should be done with nonconforming products?
- Evaluate and segregate them (correct)
- Use them after discovery of nonconformance
- Maintain procedures for rework and retest
- Dispose of them immediately
What is the purpose of Corrective and Preventive Action (CAPA)?
What is the purpose of Corrective and Preventive Action (CAPA)?
- To maintain accessible records for review and copying
- To investigate the causes of nonconformity
- To analyze work operations and quality records
- To fix problems and prevent their recurrence (correct)
Which of the following is NOT required for maintaining complaint files according to FDA regulations?
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?
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?
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?
What is the significance of the new regulations implemented in Europe for medical devices?
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