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ASQ CMDA Exam Questions
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Provided By: ASQ
- Exam: Certified Medical Device Auditor
- Certification: Certified Medical Device Auditor
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Total Questions: 267
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Updated On: Nov 27, 2024
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Rated: 4.9 |
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Online Users: 534
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Question 1
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According to the FD&C Act, if a device is characterized as being life sustaining, what should be classification of this device?
Answer: C
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According to the FD&C Act, if a device is characterized as being life sustaining, what should be classification of this device?
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Question 2
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Which type of inspection generally performed when regulatory authorities perceive a public threat, detect or suspect any fraudulent activity, counterfeit products?
Answer: D
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Which type of inspection generally performed when regulatory authorities perceive a public threat, detect or suspect any fraudulent activity, counterfeit products?
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Question 3
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What can be the best suitable ‘severity’ rating to measure the possible consequences of hazard if the hazard can result in ‘patient death’? NOTE: Rating scale from highest to lowest: catastrophic, critical, serious, minor & negligible.
Answer: C
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What can be the best suitable ‘severity’ rating to measure the possible consequences of hazard if the hazard can result in ‘patient death’? NOTE: Rating scale from highest to lowest: catastrophic, critical, serious, minor & negligible.
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Question 4
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ISO/IEC 17025 standard is applicable to _______________.
Answer: D
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ISO/IEC 17025 standard is applicable to _______________.
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Question 5
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According to 21 CFR 830, generally the UDI rule requires a UDI of a device on ______________.
Answer: A
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According to 21 CFR 830, generally the UDI rule requires a UDI of a device on ______________.