Clinical evaluation of a new medical device

#1
Hi,

Would someone be able to clarify whether:

1. you need to appraise literature data both in literature search & review and again in the appraisal stage or only during the literature search.

2. you have to separately consider every residual risk even if they are acceptable, in the analysis of clinical data stage? Or could you just consider the ones that also exist in literature and thus have clinical data pertaining to them.


Thanks for the help.
 
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