We conduct all our biocompatibility tests in state-of-the-art USDA-registered, ISO 17025 accredited and American Association for the Accreditation of Laboratory Animal Care (AAALAC) accredited facility.
We have state-of-the-art facility to conduct biocompatibility tests for Class I to III devices at our partner facility coupled with best in class technology to deliver cost effective and accurate testing solutions. Our in-depth analytics, research and design and comprehensive testing procedures will bring out the best output for you. We focus purely on biocompatibility testing to meet the requirements of FDA 510 K, CE Marking ISO 10993 or other geographies.
The key standard in biocompatibility testing is risk management process. Our systems and procedures are benchmarked to meet the exact standards of FDA and ISO. Customizing procedures as per device type, intended usage, client specification, and nature of contact with the body are the basis for all testing solutions. We conduct all in-vivo and in-vitro biocompatibility tests.
IN VIVO TESTING
|Guinea Pig Maximization||Intracutaneous reactivity||Subcutaneous||Acute systemic toxicity||Bacterial reverse mutations (AMES)||Models: Canine, porcine, Ovine|
|Buehler||Vaginal mucosal Irritation||Intramuscular||Subacute /subchronic toxicity||Chromosomal Aberration||Standard and custom|
|Bone||Chronic toxicity||Murine Mouse Lymphoma|
|Material mediated pyrogenicity||Peripheral blood mouse micronucleus|
IN VITRO TESTING
|ISO MEM Elution||Hemolysis –ASTM (Direct and extract)|
|Agarose Overlay||Complement activation (C3a and SC5b-9)|
|Direct contact||Partial Thromboplastin Time (ASTM –PTT)|
|Liquid or solid cytotoxicity||Prothrombin Time Assay (PT)|