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.
The biological evaluation of materials and substances is a key area for the regulatory authorities. We have consultants with a solid experience within this area.
The Clinical Evaluation and Clinical Investigation is getting increased attention with the new Medical Device Regulation. We know the authorities ’expectations for the content of a clinical evaluation plan and report, and we have a solid experience within literature search and preparation of CER’s.