please I need your opinion in the following:
in the presence of real time stability study confirming the resistance of the packaging with no estimation of degradation and preservation of product specifications and performance, is it mandatory to test the initial proved biocompatibilty of a non sterile MD at the end of shelf life?
if yes, please can you guide me on the most relevant biological testing to be performed? The cytotoxicity for example?
THANKS IN advance for your help.
in the presence of real time stability study confirming the resistance of the packaging with no estimation of degradation and preservation of product specifications and performance, is it mandatory to test the initial proved biocompatibilty of a non sterile MD at the end of shelf life?
if yes, please can you guide me on the most relevant biological testing to be performed? The cytotoxicity for example?
THANKS IN advance for your help.