Biological evaluation of medical devices
Service items
■ In vitro cytotoxicity test
■ Systemic toxicity test
■ Post implantation local reaction test
■ Stimulation and delayed type hypersensitivity test
■ Genotoxicity test
■ Reproductive toxicity test
■ Pre clinical animal safety and effectiveness test of medical devices
■ Non clinical animal test of medicine and machinery combination project
■ Systemic toxicity test
■ Post implantation local reaction test
■ Stimulation and delayed type hypersensitivity test
■ Genotoxicity test
■ Reproductive toxicity test
■ Pre clinical animal safety and effectiveness test of medical devices
■ Non clinical animal test of medicine and machinery combination project
Service advantages
We have conducted non clinical animal trials in accordance with GLP standards and relevant medical device regulations, and have established testing capabilities covering various categories such as in vivo hemostatic materials, neurosurgical hemostatic materials, intravascular occlusion or hemostatic materials, dental implant materials, orthopedic implant materials, and skin suture materials.
