Chiara Lorenzetto is a Principal Consultant at CardioMed Device Consultants with nearly 20 years of experience in medical device and pharmaceutical product development. She specializes in biological safety evaluation, biocompatibility, chemical characterization, and toxicological risk assessment. She helps medical device manufacturers develop risk-based biological evaluation strategies, navigate FDA and European regulatory requirements, and establish efficient testing programs to support regulatory submissions and product commercialization.
Experience
Ms. Lorenzetto is the founder of Niu Consulting, established in 2018, where she advises medical device manufacturers worldwide on biological safety assessments in accordance with the ISO 10993 series of standards and FDA guidance. Her expertise includes biological evaluation plans, biocompatibility testing strategies, chemical characterization, toxicological risk assessments, and biological evaluation reports.
She has extensive experience interacting with the FDA and European Notified Bodies to address biological safety questions and resolve regulatory concerns. She also works closely with testing laboratories to develop scientifically justified testing programs, optimize study timelines, and support efficient product development.
Earlier in her career, Ms. Lorenzetto held project management and technical leadership roles in the medical device and pharmaceutical industries, directing cross-functional teams from early product development through commercialization. She also managed laboratory activities involving in vitro and in vivo biological and biochemical assays for drug discovery and pharmaceutical product evaluation.