STEMart news

STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the launch of its Rapid Endotoxin Testing Services to help medical device manufacturers quickly and accurately assess the endotoxin levels in their products.

Bacterial endotoxins are lipopolysaccharides (LPS) bound to the bacterial cell wall and released when the bacteria rupture or brea

STEMart, a US-based provider of comprehensive services for all phases of medical device development, is proud to announce the launch of its new Particulate Matter Testing Services, offering a wide range of particulate testing from <0.001 μm to >3,000 μm. STEMart can provide accurate analysis and material characterization from nanometer scale particles to bulk powders with its various testing techniques.

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STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced the Bioburden and Sterility Testing services for medical devices under the guidance of the ISO 11731 method.

For medical device manufacturers, sterility assurance is a vital part in producing safe products. The FDA and other regulatory agencies require validation of steril

STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced Biological Indicator Sterility Testing services for the industry of medical devices. This testing is performed according to the exposure of Biological Indicators (BIs) after completion of the sterilization load, and it is a qualitative test to reveal results that can appropriately indica

STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, introduces comprehensive microbiology and sterility testing for sterile, non-pyrogenic products. STEMart has extensive expertise in microbiology as well as sterility testing and remains dedicated to a full-service experience that supports manufacturers in meeting regulatory goals

STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches Acute Systemic Toxicity testing for the medical device industry. The testing is following the biocompatibility guidelines modified for medical devices.

Biocompatibility is used to describe the appropriate biological requirements for biological materials used in medical