Medical Device Biocompatibility Testing and GLP Non Clinical Data Quality Management
Through strict GLP non clinical data quality management,it is possible to effectively reduce the bias of medical device biocompatibility test data,and improve the authenticity and completeness of the data.It is feasible and necessary to use GLP non clinical data quality management in medical device biocompatibility test,which meets the requirements of medical device safety evaluation and risk management.The article introduced the implementation of biocompatibility testing for medical devices that comply with good laboratory practice(GLP)principles both domestically and internationally,as well as the operational requirements of GLP in different industries.Starting from GLP principles,it elaborated on the key points of GLP non clinical data quality management in conducting medical device biocompatibility testing.
medical devicebiomaterialbiocompatibilitygood laboratory practicenon-clinical data quality managementrisk managementbioabsorbable stent
万方数据
维普
