Competence centre providing regulatory consulting and testing services for medical device compliance under MDR and IVDR frameworks. Offers project conception, technology assessment, accredited testing, and regulatory support for device development and market authorization.
Manufactured by
NMI Naturwissenschaftliches und Medizinisches Institut an der Universität Tübingen
Reutlingen, Germany
Since its foundation in June 1985, an interdisciplinary team of scientists at the NMI has been conducting application-oriented research at the interface of biological and material sciences. Our mission is the transfer of knowledge and technology into practice. Over the years, work at the NMI has laid the foundation for numerous economic innovations. Our research work has resulted in spin-offs that have successfully established themselves on the market, true to our guiding principle: NMI achieving results. We accompany companies and public research organizations from idea creation to market approval and market launch of news product and beyond, because we analyze and evaluate the results with the client after comprehensive testing and thus explore new areas together. Our service portfolio also includes sub-projects and individual services, such as first-class consulting, precise technology assessment, successful funding applications, concept development and/or project coordination. In addition, we offer testing services in the accredited area and thus guarantee the highest quality and reliability. Over the years, the NMI has established itself as a stable bridge between research and industry and has a solid network of collaborations and partners. In addition, the NMI is a member of innBW - the Baden-Württemberg Innovation Alliance.
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Regulatory consulting services for Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance in the European Union. Supports manufacturers with certification documentation, technical file preparation, notified body liaison, and post-market surveillance strategies to achieve CE marking and market authorization.
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Regulatory consulting service specializing in Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance. Provides strategic guidance and hands-on support for medical device market authorization and regulatory submissions across European markets.
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