Regulatory advisors will provide valuable guidance on pricing, timeline and types of testing needed, both risk management and biocompatibility start with device design and continue through production and post-production information collection and evaluation, by the way, in addition, the quality evaluation should be performed at the use point and means access to classified areas.

However, the long-term implantation studies intended for evaluation of local biological effects may provide insight into such properties, biocompatibility testing is ensuring that sterile devices are compatible with biological systems, by the same token, the evaluation of biocompatibility shall include the already available relevant experience of use of the product and the actual testing done on the final product.

Biocompatibility is a basic regulatory requirement for materials used in contact with the human body. What is actually needed is a qualified individual developing an evaluation program based on the specifics of the device.