First off, we will define the scope and strategic approach of the Clinical Evaluation. We will agree on a timeframe, including any deadlines that must be met. In this phase, we will exchange all necessary information.
The medical device in question is categorized in terms of cumulative contact duration and target tissue invasiveness.
The Biological Evaluation Plan, including the planning of in vivo tests depending on the results from the chemical/physical and in vitro tests is prepared.
Based on database research, the different acceptance criteria are defined (PharmEur, Toxnet).
It is checked whether Biocomp data of comparable products are available.
The Biocomp data are analyzed.
The data from the Biocomp tests are summarized in a Biological Evaluation Report. If adverse data are found, there is input for adjustments in the design and manufacturing process of the product.