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Examtopics Certified Medical Device Auditor (CMDA) Prepaway Real Exam Questions and dumps free download
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Certified Medical Device Auditor (CMDA)
#Question
During an inspection, a device is found to be in disrepair. What is the auditor's immediate recommendation?
A.
Increase production rates
B.
Repair the device
C.
Change suppliers
D.
Ignore the issue
Correct Answer:
B
Repairing the device is essential to maintain quality assurance and ensure compliance with regulatory standards.
#Question
An audit of supplier facilities reveals non-compliance with safety standards. What action should the auditor recommend?
A.
Conduct a follow-up audit
B.
Ignore the findings
C.
Increase orders
D.
Change suppliers
Correct Answer:
A
Conducting a follow-up audit helps verify corrective actions and compliance with safety standards.
#Question
A manufacturer receives feedback about the user interface of its medical device. What should the auditor prioritize in response?
A.
Conduct user experience testing
B.
Adjust the design immediately
C.
Change marketing strategies
D.
Increase production
Correct Answer:
A
Conducting user experience testing helps identify specific issues and enhance usability for customers.
#Question
An internal audit finds that not all employees have access to quality management documents. What should be recommended?
A.
Change document management systems
B.
Increase penalties
C.
Ignore the issue
D.
Ensure accessible document storage
Correct Answer:
D
Ensuring accessible document storage allows all employees to have the necessary resources to comply with quality standards.
#Question
A company wants to improve its response time to customer complaints. What is the most immediate focus for the auditor?
A.
Change marketing tactics
B.
Ignore customer feedback
C.
Review current complaint handling process
D.
Increase staff numbers
Correct Answer:
C
Reviewing the current complaint handling process can help identify areas for improvement.
#Question
An audit reveals that design controls are not documented properly. What should the auditor recommend?
A.
Implement a documentation review process
B.
Ignore the issue
C.
Increase product testing rates
D.
Change design parameters
Correct Answer:
A
Implementing a documentation review process ensures that all design controls are accurately recorded.
#Question
An organization discovers defects in final product inspection. What should the auditor focus on?
A.
Root cause analysis
B.
Increase production rates
C.
Ignore the defects
D.
Change suppliers
Correct Answer:
A
Focusing on root cause analysis is crucial to understanding the reasons for defects in inspection.
Certified Medical Device Auditor (CMDA)
#Question
During an inspection, a device is found to be in disrepair. What is the auditor's immediate recommendation?
A.
Increase production rates
B.
Repair the device
C.
Change suppliers
D.
Ignore the issue
Correct Answer:
B
Repairing the device is essential to maintain quality assurance and ensure compliance with regulatory standards.
#Question
An audit of supplier facilities reveals non-compliance with safety standards. What action should the auditor recommend?
A.
Conduct a follow-up audit
B.
Ignore the findings
C.
Increase orders
D.
Change suppliers
Correct Answer:
A
Conducting a follow-up audit helps verify corrective actions and compliance with safety standards.
#Question
A manufacturer receives feedback about the user interface of its medical device. What should the auditor prioritize in response?
A.
Conduct user experience testing
B.
Adjust the design immediately
C.
Change marketing strategies
D.
Increase production
Correct Answer:
A
Conducting user experience testing helps identify specific issues and enhance usability for customers.
#Question
An internal audit finds that not all employees have access to quality management documents. What should be recommended?
A.
Change document management systems
B.
Increase penalties
C.
Ignore the issue
D.
Ensure accessible document storage
Correct Answer:
D
Ensuring accessible document storage allows all employees to have the necessary resources to comply with quality standards.
#Question
A company wants to improve its response time to customer complaints. What is the most immediate focus for the auditor?
A.
Change marketing tactics
B.
Ignore customer feedback
C.
Review current complaint handling process
D.
Increase staff numbers
Correct Answer:
C
Reviewing the current complaint handling process can help identify areas for improvement.
#Question
An audit reveals that design controls are not documented properly. What should the auditor recommend?
A.
Implement a documentation review process
B.
Ignore the issue
C.
Increase product testing rates
D.
Change design parameters
Correct Answer:
A
Implementing a documentation review process ensures that all design controls are accurately recorded.
#Question
An organization discovers defects in final product inspection. What should the auditor focus on?
A.
Root cause analysis
B.
Increase production rates
C.
Ignore the defects
D.
Change suppliers
Correct Answer:
A
Focusing on root cause analysis is crucial to understanding the reasons for defects in inspection.
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