New York, USA – July 30, 2021 – STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now introduces multiple medical device hemocompatibility testing services for the medical device industry, such as in vitro coagulation, in vivo thrombogenicity, and complement activation following the biocompatibility guidelines modified for medical devices.
STEMart offers comprehensive services for medical device developments through all phases, from the initial ideation stage, through product design, development and validation up to manufacturing and launch. Its medical device development services cover across diverse product categories, including medical imaging devices, surgical equipment, therapeutic devices, patient monitoring, drug delivery systems, emergency care systems, oral appliances, automated lab equipment, food safety products and more.
In this release, STEMart introduces multiple test types for Hemocompatibility biocompatibility testing including hemolysis, in vitro coagulation, in vivo thrombogenicity, and complement activation following the biocompatibility guidelines modified for medical devices. For instance, the hemolysis (plasma hemoglobin) test, which is regarded as an especially significant screening test to perform in biomaterials of a medical device that has direct or indirect circulating blood contact as its measuring the red blood cell membrane fragility. The method used is one of the normative standard test methods for hemolysis. The hemolysis testing including circulating blood loops and the single pass-through assays.
Another is the in vivo thrombogenicity test that determines a relative thrombo-resistant for medical devices contacting circulating blood. This test helps manufacturers to define whether the medical device causes harmful effects on humans. Light microscopy (adhered platelets, leukocytes, aggregates, erythrocytes, fibrin, etc.) are used for thrombosis test, and light microscopy can be replaced by scanning electron microscopy if the nature of the material presents technical problems for light microscopy.
The complement activation test is used to evaluate the potential of complement activation by a medical device. The test is performed by incubating the test article and predicate in human serum and subsequently tested for the presence of the complement protein SC5b-9. This test is designed for medical devices that have interactions with blood to meet the immunology testing requirement.
“STEMart brings full-service covering all development phases to accelerate your medical device project. In our medical device development service, you have an expert, multidisciplinary, technical partner that can support your project in every way, and you can access these resources at any stage of medical device product development. The medical device development team helps you make clear definitions and smart choices that protect you from costly mistakes, ensure the desired quality and increase your speed to market.” said Tina Frederick, Executive Director of Marketing at STEMart.
STEMart is an industry-leading eCommerce platform with an expanded global footprint and has a broad portfolio of more than 10,000 products. It aims to provide best-in-class lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage towards the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer, and through that to accelerate access to better health for people everywhere.