Luisa Mella

Luisa Mella is a seasoned professional in quality assurance and regulatory affairs with extensive experience in the medical devices sector. Currently serving as Director of Global Quality and EMEA Regulatory at Asensus Surgical since October 2017, Luisa leads an international team and oversees critical quality and regulatory strategies across multiple regions including Italy, the US, and Israel. Previous roles include positions at Copan Group, OVERMED SRL, and Medacta International, where responsibilities encompassed managing compliance with various regulatory directives, overseeing premarket submissions, and ensuring adherence to quality management systems. Luisa also contributes to the field as an independent teacher for medical device quality assurance and regulatory affairs courses. Academic credentials include a degree in Biomedical Engineering from Politecnico di Milano and a Master in Pharmaceutical Marketing and Management focused on regulatory affairs from Alma Laboris, complemented by managerial development training from SDA Bocconi.