Biocompatibility Testing Services

Biocompatibility testing requirements comes into effect if a product is scheduled for Pre-Market Approval (PMA) or 510k submissions. Biocompatibility testing determines the biological reaction of a body to a product/device that comes in contact with it for a defined duration.

Toxikon has performed numerous safety studies, which has given us good experience and knowledge for many years. All studies are performed in compliance with guidelines established by the regulatory agencies. The protocols are designed to meet the regulatory requirements for ISO, OECD, and Japanese MHLW.

Toxikon offers expertise in the following testing services:

• Cytotoxicity
• Sensitization
• Irritation/Intracutaneous Reactivity Tests
• Systemic Toxicity (Acute)
• Toxicity Tests (Subacute to Chronic)
• Implantation Tests
• Genotoxicity
• Hemocompatibility
• USP Class VI Tests
• Carcinogenicity
• Immunotoxicity
• Dermal
• Ocular

Toxikon is a full service laboratory and offers integrated approach to your testing requirements. In conjunction with biocompatibility testing services, Toxikon also offers support services such as analytical and bioanalytical chemistry services, PK/TK, and statistical analyses.