D
dionysisf
Hello,
We are a medical device manufacturer, manufacturing Class IIb products.
Our clinical evaluation study has been produced by us some years ago, using 2 clinical trials and literature assessment.
As we are facing issues with this evaluation study during registrations to non-EU countries and during auditors reviews, we would like to update it and to subcontract it.
Could you please advice us whether we can use a "clinical evaluation" expert/company to perform the clinical evaluation for us? If yes, do you know any company having such expertise?
Thanks in advance
We are a medical device manufacturer, manufacturing Class IIb products.
Our clinical evaluation study has been produced by us some years ago, using 2 clinical trials and literature assessment.
As we are facing issues with this evaluation study during registrations to non-EU countries and during auditors reviews, we would like to update it and to subcontract it.
Could you please advice us whether we can use a "clinical evaluation" expert/company to perform the clinical evaluation for us? If yes, do you know any company having such expertise?
Thanks in advance