Thema

Thema is a strategic regulatory consulting firm specializing in the medical device and in vitro diagnostic (IVD) sectors. Founded in Italy and part of the Complife Group, the company expanded its operations to the United States in 2024 with a headquarters in Philadelphia's B+labs incubator. Thema provides comprehensive services including CE marking support, FDA pre-market submissions (510(k), De Novo, PMA), and quality management system implementation (ISO 13485, 21 CFR 820). The firm serves as a critical partner for life science companies navigating complex international regulatory landscapes to achieve market access and maintain compliance. Its expertise spans the European Union, United States, and other global markets, offering local representative services such as EU Authorized Representative and Swiss CH REP.