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The document contains multiple-choice questions related to medical devices, including definitions of 'Sterile Medical Device' and 'Product.' It also addresses 'Post Market Surveillance' and its components. The questions assess knowledge on manufacturing processes, sterility requirements, and customer complaint handling.

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Sandeep kulkarni
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79 views1 page

3

The document contains multiple-choice questions related to medical devices, including definitions of 'Sterile Medical Device' and 'Product.' It also addresses 'Post Market Surveillance' and its components. The questions assess knowledge on manufacturing processes, sterility requirements, and customer complaint handling.

Uploaded by

Sandeep kulkarni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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1.

“Sterile Medical Device”


a. Medical device manufactured by using special processes
b. Medical device intended to meet the requirement for sterility
c. Product provided by a party outside the organization’s quality management system
d. All of the above
e. None of the above

2. Product” is result of a process


a. True
b. False
c. None of the above

3. Post Market Surveillance”


a. Receiving and analyzing the “Customer complaint”
b. Responding to the customer on the received customer complaint
c. Systematic process to collect and analyze experience gained from medical device that
have been placed in the market
d. All of the above
e. None of the above

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