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Clinical Benefit of device that only aids in a process for managing or treating disease

mf389

Starting to get Involved
#1
How are others documenting the clinical benefit of a device that only aids in a process for managing or treating disease.

If a device (with several alternates) is intended to be used as one of several steps to complete a procedure, what are the clinical benefits?

Can it be stated simply as the benefit of the device is to aid in the process, or does it need to be very specific? Examples are appreciated.

For example: forceps or something similar
 
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Ed Panek

QA RA Small Med Dev Company
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#2
"Only aids" and "aids" are the same in your first sentence. I would rewrite your first sentence removing the word "only" as it causes confusion.

How many steps are involved in a process is not really relevant. Has your device been used in a clinical manner?
 
#3
How are others documenting the clinical benefit of a device that only aids in a process for managing or treating disease.

If a device (with several alternates) is intended to be used as one of several steps to complete a procedure, what are the clinical benefits?

Can it be stated simply as the benefit of the device is to aid in the process, or does it need to be very specific? Examples are appreciated.

For example: forceps or something similar
W
How are others documenting the clinical benefit of a device that only aids in a process for managing or treating disease.

If a device (with several alternates) is intended to be used as one of several steps to complete a procedure, what are the clinical benefits?

Can it be stated simply as the benefit of the device is to aid in the process, or does it need to be very specific? Examples are appreciated.

For example: forceps or something similar
What regulatory requirement do you want to fulfil specifically?
 
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