Devices Diagnostics

Medidee Services (Deutschland) GmbH

Medidee specializes in providing support in the areas of compliance, quality, regulatory and clinical for medical devices and in vitro diagnostics. The success is based on a unique team that combines science and practice. With offices in Switzerland, Germany, Denmark, Belgium and the USA they are internationally represented. Medidee supports its customers and their products from the project idea through development, verification, clinical validation and market access for global markets.

Competences

Regulatory Affairs / Compliance, Biological Risk Assessment (ISO10993), Clinical Evaluations MDR / IVDR, Clinical and Performance Studies, ISO13485, 21CFR820, MDSAP, EU Representative

Address

Hohnenweg 9
DE-78098 Triberg

Web: www.medidee.com

Contact

Heiko Bähr
Senior Consultant
Tel.: +49 163 237 76 66
E-Mail: heiko.baehr@medidee.com