Clinical Investigation vs. Bench Test - Definition

LievenDW

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#1
Hi,


Is every test with a medical device (before CE marking) in a clinical setting regarded as a clinical investigation? If not, what are the criteria to distinguish a clinical investigation from a bench test?
 
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SteveK

#2
Re: Clinical investigation - definition

Hi,


Is every test with a medical device (before CE marking) in a clinical setting regarded as a clinical investigation? If not, what are the criteria to distinguish a clinical investigation from a bench test?
Have look at the guidelines at the GHTF site:

http :// www. ghtf. org/sg5/sg5-final.html - DEAD (404) LINK UNLINKED

Steve
 
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