Mannheim, Baden-Württemberg, Germany
At TheraGenesis, we are focused on the development of innovative medical devices in Europe. Established in 1995, we have supported blue-chip medical device manufactures and start-up entrepeneurs to bring their products to market and beyond. Such products have extended to virtually all areas of interventional medicine. Our range of services include all aspects of clinical study management throughout Europe, as well as Authorized Representative mandate per European Medical Device Directives. Our regulatory experience extends to all European countries. Through our partnership with IMARC Reseach Inc., our bandwidth of support include USA development. Once products have reached the marketplace, together with our partner medeuronet, we support the creation of the business operational structures to put these new products into the hands of clinicians addressing such issues as distribution and logistics, reimbursement, sales and marketing.
Regulatory and clinical development of medical devices in Europe.
Management of pharmaceutical and medical device clinical programs in Germany, Austria, Switzerland, Italy, Poland and the Netherlands.
Establishment of European subsidiary providing CRO Services
Established and managed international clinical studies monitoring and quality assurance department.
Various clinical development management positions in USA and Europe.