Author name: Staci

Chemical Characterization is a powerful methodology for addressing biocompatibility endpoints, providing a risk assessment of biocompatibility using chemical, biocompatibility, and patient exposure data. Chemical Characterization involves the extraction of the device with various solvents, chemical analysis of compounds extracted from the device, and an evaluation of the toxicological risk associated with the patient exposure to the […]

Genetic toxicology testing evaluates the potential of the test material to induce the gene mutation or chromosome damage using a range of bacterial, mammalian cells in vitro and in vivo test systems. STEMart offers multiple test types for genotoxicity biocompatibility testing, following the OECD guidelines modified for medical devices and performing under GLP conditions. Genetic Toxicology Testing for Medical Devices Bacterial

Hemocompatibility testing is designed for medical devices contacting circulating blood. Biomaterials that contact blood could have cellular effects and humoral effects including thrombosis, embolism, activation of the coagulation, etc. For devices contacting with circulating blood, hemocompatibility testing is generally required as a biocompatibility assessment. STEMart offers multiple test types for Hemocompatibility biocompatibility testing including hemolysis, in

Cytotoxicity testing is a sensitive method to assess the biocompatibility of a material extracted through a specific cell culture media following exposure of the extracted fluid to L929 cells. This test is performed on raw materials in the manufacturing process, all medical devices contacting patients, and devices undergoing a sterilization validation. STEMart provides a wide range