Consultant, Regulatory Affairs (Latin America)

Lilian Pinheiro has over 10 years of medical device industry experience, primarily focused on high-risk IVD devices, including immunohematology and blood virus diagnostics. She is instrumental in assisting local manufacturers to understand and implement European MDR and IVDR. Lilian's background includes extensive experience in Brazil ANVISA activities, such as Registro applications; prior analysis (INCQS); regulatory research and pathways; import/export processes; company licenses for controlled substances (Brazilian Army and Federal Police); and environmental licenses.