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    We believe in the need for regulations and the opportunities they can create.

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    We have a proactive
    approach to regulatory

Quality management

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.

BioTop Medical werkt samen met u

Our objective is to establish customised strategies to achieve and maintain regulatory compliance in a flexible, efficient and effective manner.

We support our clients with the development and implementation of tailored processes required to bring their products to the market, and by providing them with hands-on management of Regulatory Affairs and Quality Assurance activities.

BioTop Medical builds long-term relationships with its clients ensuring in depth product and process knowledge.

For direct contact call +31 (0)71 528 01 12


Are you ready for the MDR?


Do you need a gap analysis?


Do you need "hands-on" support?
On the TD? On the QMS?


Call us now, we can help you!


Let us help you with your documents

We conduct literature searches;

We collect and assess clinical datasets and write clinical evaluation reports (CERs);

We lead and oversee the risk management process;

We write the biological safety assessment report.