trainings

trainings Our trainings (also in-house training) are customized to the specific and individual needs of the customers. We provide international training on European and US FDA regulatory aspects including: / CE marking of medical devices / preparation of technical files / risk management according to ISO 14971 / preparation of clinical evaluation / post-market surveillance strategies / vigilance requirements / CAPA system handling / vigilance master plan / biocompatibility evaluation / toxicological evaluation of extractables/leachables / quality management systems