Head Clinical Affairs
i.DRAS GmbH – HWI Group
- Competence: Medical devices, clinical affairs, regulatory affairs services for Medical devices and medicinal products
- Markets: EU, Germany
Dr. med. Christian Schübel studied medicine at the Ludwig-Maximilians-University in Munich and obtained his MD in 1989. From 1989 to 1995 he worked as a surgeon by training at the surgical department at the Klinikum Grosshadern and other hospitals. For two and a half years he was employed at a CRO, Verum Staticon GmbH, responsible for the management of clinical trials, especially in the fields of cardiology, surgery, and anesthesiology. For 13 years he was in charge of the clinical affairs department at TÜV SÜD Product Service GmbH as notified body for the certification of medical device for the European market.
His current work as Head of Medical Affairs at i.DRAS GmbH is providing services for clinical evaluation of medical devices and combination products. He is a member of the German Association for Pharmaceutical Medicine (DGPharMed) and member of the ethics committee of the Bavarian Medical Association.
“Based on the implementation of the new Medical Device Regulation in the European Union, the requirements for the market access of medical software are increasing tremendously. In addition, the conformity of stand-alone medical software has to be assessed by Notified Bodies prior entering the market. VDE Medical Software offers most reliable and current information accelerating the market access.”