Our experienced team from a variety of scientific disciplines guarantees a quick, flexible, individual and professional project management that enables you to bring your products to market faster! Based on decades of practical industry experience, extensive know-how and our knowledge advantage, we can support you very efficiently and pragmatic in preparing the necessary documentation for your products and processes.
We manage
► All risk categories including In Vitro Diagnostics and active medical devices
► Combination products (medical devices with a pharmaceutical active ingredient)
► Software
Our goal
► CE marking of your medical devices for the European market
► International registrations (e.g. 510(k) for USA)
► Quality Management System in accordance with ISO 13485