BioTop Medical helps medical device companies to bring their products to the European and North American markets. This is accomplished by establishing a strategy to achieve and maintain regulatory compliance. We support the companies in the development, tailoring and implementation of the required processes and provide hands-on management of the Regulatory Affairs and Quality Assurance activities. BioTop Medical builds long term relationships ensuring in depth product and process knowledge.
Fundamental values of the organisation are: honesty, integrity and knowledge.
We believe in the need for regulations. We understand the restrictions but also the opportunities they can create.