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