No repetition of animal testing to re-proof Biocompatibility in case of product & manufacturing changes

Product and manufacturing changes happen on a regular base within development and production of medical devices. These changes raise the question, if biological safety is still given and performed biocompatibility studies are still applicable after the change.

The webinar lists possible changes of the product and the manufacturing process that can occur. Approaches will be described to analyse the impact of the different changes on biocompatibility and/or how to address them e.g. by available information, by the bridging approach with chemical characterisation etc. Furthermore, possibilities will be suggested how to avoid animal testing e.g. by using in vitro studies within change assessment.

The webinar will offer you best practices to assure the biological safety of your medical device after product or manufacturing changes in compliance with actual guidelines and particular emphasis on avoiding animal studies.