Our medical device biocompatibility expertise at your service
Niu Consulting provides companies with considerable expertise in assessing the biocompatibility of their medical devices.
Founder of Niu Consulting, Chiara Lorenzetto is a trained biotechnologist. She began her professional career working in the pharmaceutical sector, which has always been very strictly regulated. Initially, she focused on the study of molecules that are able to slow down neurodegenerative diseases, then she focused on the treatment of inflammation and autoimmune diseases. Finally, she conducted research on kinase inhibitors.
Years of work in pharmaceutical research laboratories have enabled her to become familiar with a wide range of safety and efficacy tests, conducted both in vivo and in vitro. Among others, Chiara Lorenzetto’s task was to adapt these tests, conducted on the basis of international best practices, to the specific drug under investigation.
Subsequently, Chiara Lorenzetto moved on to dealing first with complex medical devices with permanent implantation (such as heart valve prostheses), then with diagnostic devices used in the clinical area of infectious diseases. She conducted this work as a project manager in charge of coordinating the activities of the team dedicated to the design and development of new medical devices. Her role always involved the coordination of the contribution of various partners (industries, universities, research bodies) and company departments focused on different aspects of the development project.
The combination of these experiences today makes Chiara Lorenzetto an extremely competent figure in a wide range of physical-chemical-biological validation tests, in the evaluation of the results obtained, and in their formal presentation to the relevant regulatory bodies. Included among the services most requested of Niu Consulting is the biocompatibility assessment of new medical devices, essential for obtaining the CE mark or FDA approval, and for their marketing by the manufacturers.
