Who we work with

Compliance with the regulatory requirements for medical devices is essential to launch your medical device to the market. Since 1997, BioTop Medical provides services related to the development and the maintenance of quality management system and to regulatory affairs related to medical device companies.  From that perspective, we support companies bringing their products to the European, USA, Canadian and Brazilian markets and (development, production) subcontractors of medical device manufacturers, as well as importers and distributors of medical devices in Europe. Our approach takes into account your needs and the specific business and market situation. Our objective is to establish customized strategies to achieve and maintain regulatory compliance in a flexible, efficient and effective manner.