Product

In Vivo Biocompatibility Testing Services for Medical Devices

August 12, 2014

Biocompatibility testing requirements come 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, USP, OECD and Japanese MHLW.

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