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.
关键词
医疗器械/生物材料/生物相容性/良好实验室规范/非临床数据质量管理/风险管理/可吸收支架
Key words
medical device/biomaterial/biocompatibility/good laboratory practice/non-clinical data quality management/risk management/bioabsorbable stent
维普
万方数据