STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, recently introduces comprehensive — medical device biocompatibility testing for both in vitro and in vivo assessments to the life science and medical community, such as medical device cytotoxicity testing, hemocompatibility testing service, and implantation with histopathology testing service.
Biocompatibility is used to describe appropriate biological requirements of biomaterials used in a medical device, which has also been described as the ability of a device material to perform with an appropriate host response in a specific application. Its assessment is a necessary part of the overall safety evaluation of a medical device. FDA has also developed International Standard ISO 10993-1 for medical devices to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body.
STEMart offers comprehensive biocompatibility testing for both in vitro and in vivo assessments, such as cytotoxicity testing, hemocompatibility testing, implantation with histopathology testing, risk assessment, sensitization test, chemical characterization service, and subacute and subchronic toxicity test. With extensive expertise in biocompatibility testing, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks.
For example, for cytotoxicity, STEMart offers medical device cytotoxicity testing to assess the biocompatibility of a material extracted through a specific cell culture media following exposure of the extracted fluid to L929 cells. For acute systemic toxicity & pyrogenicity, STEMart offers the acute systemic toxicity and pyrogenicity test to provide information about health hazards potentially to arise from an acute exposure form a medical device. In addition, STEMart offers the Biocompatibility Evaluation to assess contaminants from the air emitted from the device when the gas pathway is expected to contact a patient via the respiratory tract.
"STEMart performs cost-effective services that deliver reliable results for clients' medical devices. Our experts can evaluate the medical device to propose an appropriate plan for testing to ensure your medical device meets the required regulatory compliance." said Brian N. Griffith, Product Portfolio Manager at STEMart.
"Combining the expert medical product testing knowledge with the state-of-the-art laboratories and facilities, SETMart provides customers a one-stop, client-specific approach for testing of both active medical devices, non-active medical devices and In Vitro Diagnostic equipment. With the increased demand for medical device testing, SETMart now introduces our clients full set of medical device biocompatibility testing services to provide professional solutions to support them in the medical industry." said Tina Frederick, Executive Director of Marketing at STEMart.
If you have any additional questions about biocompatibility testing, or would like to consult with the experts at STEMart, please feel free to contact us or visit us at https://www.ste-mart.com/.
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.
Name: Staci Horme
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Release ID: 89002750