In general, biocompatibility is the ability for materials to interact with the biological system without causing any harm.

Biocompatibility can be a complex process as many medical devices are made of more than one material. The current leading standard for biological evaluation of medical devices is ISO 10993 at its latest version. Much of the pre-clinical testing of the materials is not conducted on the devices, but rather on the material itself. However, at some stage the testing has to include the device since factors such as, the device shape, geometry and surface treatment may affect its biocompatibility.

We can assist you in the evaluation of your device and its materials for biocompatibility compliance and provide step by step guidance or online consulting. Contact us for biocompatibility validation planning and testing services.

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