Reutlingen, Baden-Württemberg, Germany
With over 25 years of experience, I am leading MEDAGENT GmbH as CEO, driving excellence in regulatory affairs and quality management systems for medical devices. My expertise spans ISO 13485, MDD 93/42 EEC, MDR 2017/745 EEC, FDA and international device registration. Committed to advancing global healthcare, I strive to simplify regulatory compliance and empower device manufacturers to bring innovative medical solutions to market. I am passionate about fostering collaboration and aligning with client goals to ensure compliance and improve patient safety worldwide. At MEDAGENT I oversee comprehensive medical device regulatory services, including CE, FDA, CMDCAS, ANVISA, and other international premarketing applications, while managing U.S. Agent, European Representative, BRH, UKRP and Australian Sponsor services. Leveraging my skills in regulatory submissions and medical device manufacturing, I guide organizations in navigating complex compliance landscapes and achieving global market access.
We are specialized in regulatory affairs and quality management systems related to medical devices. Specialities: - ISO 13485 / 21CFR820 - MDD 93/42 EEC - MDR 2017/745 EEC - CE, FDA, CMDCAS premarketing applications - International registration of medical devices - U.S. Agent, European Representative Service, UK Responsible Person, Brasilian Registration Holder and Importer
MEDAGENT, Inc. is primarily acting as U.S. Agent for and Medical Device Manufacturers. In 2013 a Logistic Hub for medical devices has been established in Portsmouth, NH.