The clinical evaluation has a special impact on risk management
The results of the clinical evaluation significantly influence the risk management. Only the clinical evaluation can confirm the assumptions for the benefit and thus the acceptance of a certain benefit-risk ratio as presented in the risk management file. The clinical assessment must also confirm the assumptions in the risk management file on the risks. The results of the CE-approved follow-up should also be considered in clinical evaluation and risk management.
The clinical evaluator Prof. Zenner and partners can support the company in the comparison and clinical writing of the risk management file.