safety testing | qualification | validation

safety testing | qualification | validation In cooperation with international strategic testing houses we provide risk-based solutions for product safety testing and evaluation such as biocompatibility assessment according to ISO 10993-1 ff, extractables and leachables testing according to ISO 10993-18 and toxicological evaluation of medical devices and container closure systems for drug products. In addition we provide solutions for equipment qualification and process validation with specific expertise in sterilization technologies. / product and production risk management / biocompatibility and toxicological testing and evaluation / preparation of validation master plans / equipment qualification / process validation / sterilization validation