In Vitro and in vivo biological evaluations of Medical Devices



At TIPS journal club meeting held on 24.06.2019, the biological evaluation of medical devices was presented by S. Mohammadi Nejad. The market of medical device (global market and country market) and importance of biological safety were explained. The whole process of medical device manufacturing, the importance of pre-clinical evaluations and the related standards to the medical device industry, specially the ISO 10993, were described. With an overview to the cytoxicity and genotoxicity assays, the role of TIPS in regulatory testing was discussed.