Market access

Compliance with the regulatory requirements of medical devices is essential to launch your product to the market. Since 1997, BioTop Medical provides services related to quality management system and regulatory affairs to medical device companies, thus supporting them bringing their products to the European and North American markets. The approach we favour, takes into account your regulatory needs and specific business and market situation. Our objective is to establish customised strategies to achieve and maintain regulatory compliance in a flexible, efficient and effective manner.