Medical Device Microbiological Testing


Medical Device Microbiological Testing

Microbiological testing evaluates the microorganisms present in medical devices and helps to reduce the risk of microbial contamination to reduce the risk of infection for patients, users, or third parties. Microbiological testing is an essential factor in the quality and safety control of medical devices, and it is also one of the requirements of medical device regulations worldwide.

The results of microbiological testing can reflect the quality of the control system for medical device production. Most medical devices that come into contact with humans need to be tested for microbiological limits.

About Us

We provide accurate microbiological testing of medical devices according to safety and certification requirements stipulated by the latest global standards and regulations.

Our company provides comprehensive, high-quality microbiological testing services for all types of medical devices to assist medical device manufacturers in complying with the requirements of microbiological and sterilization safety regulations. Our team of expert staff specializes in global medical device safety and certification requirements. We are committed to saving manufacturers a lot of time and resources, and helping manufacturers successfully achieve the purpose of bringing medical devices to the global market.

Scope of Our Services

  • Sterility testing

Sterility testing is used to inspect medical devices that are required by law to be sterile or claimed to be sterile to ensure that they do not contain live microorganisms. Our sterility check methods include membrane filtration or direct inoculation.

  • Bacterial endotoxin detection

Bacterial endotoxin is a complex of lipopoly saccharide and protein on the cell wall of Gram-negative bacteria, which is released when bacteria die or undergo autolysis. When endotoxin enters the bloodstream in large quantities, it causes a febrile reaction, the pyrogen reaction. We performed an in vitro LAL bacterial endotoxin test (BET) to detect and quantify bacterial endotoxin in medical devices.

  • Biological load testing

Biological load testing is designed to detect the total number of microorganisms visible in a medical device. Validation of the assay must be performed before actual biological load testing of medical devices can be performed. We provide accurate and reliable biological load method validation and counting services.

  • Antimicrobial efficacy testing

Antimicrobial efficacy testing is an assessment of the surface of a medical device to determine its ability to kill and eliminate microbial growth. We employ contact or rinse methods to test medical devices for their effectiveness against Staphylococcus aureus, Escherichia coli, Candida albicans, and other strains. Medical devices that are subject to antimicrobial efficacy testing are often products with claims of antimicrobial efficacy.

  • Microbial limits testing

Microbial limits are used to check the degree of microbial contamination of medical devices and whether regulatory requirements are met. We comply with national regulatory requirements, providing testing services for aerobic bacteria, mold and other strains, as well as initial contamination bacteria inspection.

With a highly professional team and laboratories accredited to international standards, we have the capacity to handle all the testing, analysis, measurement, evaluation and report generation services required for medical device registration.

If you need help or have a question, please feel free to contact us for more details.

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