Biological & Clinical Evaluation
Do you need to update the biological or clinical evaluation of your medical devices?
We can assist you in evaluating and updating your current documentation in accordance with ISO 10993; Biological Evaluation of Medical Devices.
A Clinical Evaluation Report (CER) is a comprehensive analysis of pre-marketand post-market clinical data relevant to a medical device. We can support you in the preparation of the CER, including the establishment of literature search protocol, description of “state of the art” and all the literature research.