Our focus:
MDR consulting and services for medical devices such as quality management, risk management, clinical data and studies or clinical evaluation.

Our project overview:
45+ medical device projects (from idea to product)
120+ dossiers
20+ patents

Our expertise profile
Certified according to DIN EN ISO 13485:2016, Medical Device Regulation (MDR), Medizinprodukterechtdurchführungsgesetz (MPDG), expert knowledge in GCP and GMP as well as ISO 14155 and always up-to-date expertise.

Company profile:
Founded in 2003
10+ in-house specialists
a number of satisfied customers

Our project partners:
Mediconomics GmbH (Europe/USA/Canada)
DNV MedCert GmbH (Germany)