Toxicological assessment of risk of medical devices

Estimation of the possible toxic effects of medical devices (MDs) directed toward only problems associated with exposure route and dose, exposure to some by-products produced during the synthesis of MDs, as well as matrix effects. Moreover, more developments are required to enhance methodology and analysis predictability for estimating the immune/particulate toxicity. However, developing techniques are being proposed for determining blood compatibility, fibrosis, and adhesion. To develop an effective MD, it is crucial to assess the possible toxicities associated with the employed substances/polymers in the MDs. This chapter discusses the factors influencing toxicity, toxicity testing methods (e.g., carcinogenicity, cytotoxicity, pyrogenicity, genotoxicity, etc.), and toxicological risk assessment.