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Biocompatibility is used to describe appropriate biological requirements of biomaterials used in a medical device.
Biocompatibility has also been described as the ability of a device material to perform with an appropriate host
response in a specific application. Biocompatibility assessment is a necessary part of the overall safety evaluation
of a medical device.
FDA has developed International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation
and testing within a risk management process" to assist industry in preparing Premarket Applications (PMAs),
Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s)
for medical devices that come into direct contact or indirect contact with the human body in order 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. With
expertise in biocompatibility testing, STEMart can provide a full-service experience, support manufacturers to meet
the regulatory goals, and minimize the compliance risks.
We offer 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.
We offer hemocompatibility testing services for medical devices that contact circulating blood. Our service including multiple types of tests depending on your product and customized needs.
We offer implantation with histopathology testing service to help manufacturers to assess the impact of the implanted material on surrounding tissues.
We offer irritation tests to determine if a chemical or material of the medical device will cause local irritation in the skin, ocular tissues, or mucosal.
We offer toxicological risk assessment, biological risk assessment, biological evaluation plan, biological evaluation report, and gas analysis services.
We offer the sensitization test to determine the sensitizing activity of medical devices. These tests are assessing the potential of a medical device to cause a delayed hypersensitivity reaction.
Our chemical characterization services including Extractable & Leachable, Degradation Products, Residual Ethylene Oxide, Material & Product Stability, Dissolution, Raw Materials Purity tests.
We offer the subacute and subchronic toxicity test to discover the effects of material with repeated exposure would have on patients.
We offer the acute systemic toxicity and pyrogenicity test to provide information about health hazards potentially to arise from an acute exposure form a medical device.
We offer 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-effectiveness full services that deliver reliable results for your 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. 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.