Work with an expert for medical device regulations in Germany and Austria
Medical device regulations and market environment increasingly demand clinical data for market approval, reimbursement, and therapy acceptance. With the Regulation (EU) 2017/745 (EU MDR)) coming into effect, rules for the conduct of clinical investigations to generate the mandatory clinical data have become more complex. In addition, the scientific community expects powerful clinical data for CE marked medical devices for therapy acceptance.
For your investigational device, you are looking for a local partner with extensive experience in dealing with the German and Austrian Competent Authorities (BfArM, BASG) and Ethics Committees to conduct your clinical investigation. Furthermore, you might need radiation agency submission management in Germany (Bundesamt für Strahlenschutz (BfS)).
After obtaining CE-mark for your device, you are looking for a partner to obtain timely and cost effective approvals to conduct your post-CE-mark research program.
Services
Dr Heike Vonhausen will work along side with your team to conduct your clinical investigation in Germany. Benefit from more than 25 years of clinical research experience. You will work with a highly professional clinical research specialist, experienced in the conduct of medical device trials, especially in the field of cardio-vascular intervention.
Experience
For more than 13 years, consultant services are offered pre- and post-CE-mark in therapeutic areas such as vascular intervention, mitral regurgitation, acute stroke, interventional cardiology, AAA, carotid barostimulation. Prior to starting her own business, Dr Vonhausen has aquired 10 years of expertise by working for a global Medical Device Company specalized in cardio-vascular products. Positions include Clinical Specialist, Manager Clinical Research and Outsourcing Manager. Furthermore, she has worked for a market leader in contract clinical research (CRO) as International Project Manager and Clinical Research Associate (CRA).