STEMart Releases New Medical Device Cytotoxicity Testing Services
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, recently introduces a series of medical device cytotoxicity testing service to advance the medical device development and facilitate the manufacturers submitting their medical device for regulatory approval.
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 now provides a wide range of in vitro cytotoxicity assays to qualitatively and quantitatively evaluate the ability of medical device to damage cells or tissues. There are qualitative methods and quantitative methods.
For qualitative methods, STEMart offers Extraction Method/ MEM Elution, Agar Diffusion/ Agarose Overlay Assay, and Direct Contact. For Direct Contact, the test material is placed directly onto cells growing on culture medium without the agar layer, cell cultures are grown to a standard monolayer, and the cells are then incubated for 24 hours at 37 ℃. During the incubation, leachable chemicals in the test material can diffuse into the culture medium and contact the cell layer, examining the monolayers for the presence of morphological changes, reduction in cell density, or lysis of cells to indicate the cytotoxicity.
For quantitative methods, STEMart provides MTT Assay often used in determining cell viability, Calcein Assay for the testing of cell viability, Neutral Red (NR) Assay, and Lactate Dehydrogenase (LDH) Leakage Assay. STEMart is able to perform comprehensive and cost-effective biocompatibility testing services to deliver reliable results for clients' medical devices. Its experts can evaluate the medical device to propose an appropriate plan for testing to ensure the medical device meets the required regulatory compliance.
"There is an increasing desire within the medical device community for biocompatibility testing to support science applications. We are delighted to introduce our clients with full set of medical device biocompatibility testing services to support them in the medical industry. We always make efforts to provide professional scientific services that create value for our customers and solve their troubles. We're a part of the industry and we'd like make some difference through the delivery of professional solutions." said Tina Frederick, Executive Director of Marketing at STEMart.
If you have additional questions about cytotoxicity or would like to find out more about the medical device cytotoxicity testing service, please visit 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.