Zobrazeno 1 - 2
of 2
pro vyhledávání: '"medical device regulation mdr 2017/745"'
Autor:
Søren Overgaard, Thomas M Grupp, Rob GHH Nelissen, Luca Cristofolini, Anne Lübbeke, Marcus Jäger, Matthias Fink, Sabine Rusch, Hassan Achakri, Francesco Benazzo, Dario Bergadano, Georg N Duda, Christian Kaddick, Volkmar Jansson, Klaus-Peter Günther
Publikováno v:
EFORT Open Reviews, Vol 8, Iss 7, Pp 509-521 (2023)
With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process. The EFORT Implant and Patient Safety Initiative WG1 ‘Introduction of
Externí odkaz:
https://doaj.org/article/a5cf775545964c91bb2f720769199354
Autor:
Overgaard S; Department of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital, Copenhagen, Denmark.; Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark., Grupp TM; Aesculap AG Research & Development & Medical Scientific Affairs, Tuttlingen, Germany.; Department of Orthopaedic and Trauma Surgery, Ludwig Maximilians University Munich, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany., Nelissen RG; Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands.; Technical University Delft, Delft, the Netherlands., Cristofolini L; Department of Industrial Engineering, School of Engineering and Architecture, Alma Mater Studiorum - Università di Bologna, Bologna, Italy., Lübbeke A; Division of Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Switzerland.; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK., Jäger M; Department of Orthopaedics, Trauma & Reconstructive Surgery St. Marien Hospital Mülheim an der Ruhr & Chair of Orthopaedics and Trauma Surgery University of Duisburg-Essen, Essen, Germany., Fink M; TÜV Süd Product Service GmbH, Clinical Centre of Excellence, Munich Germany., Rusch S; Aesculap AG Research & Development & Medical Scientific Affairs, Tuttlingen, Germany., Achakri H; Zimmer Biomet, Clinical, Regulatory & Quality Affairs, Winterthur, Switzerland., Benazzo F; IUSS Pavia, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy., Bergadano D; Medacta International SA, Medical Affairs, Castel San Pietro, Switzerland., Duda GN; Julius Wolff Institute and Center for Muskuloskeletal Surgery, Berlin Institute of Health at Charité Universitätsmedizin Berlin, Germany., Kaddick C; EndoLab Mechanical Engineering GmbH, Riedering, Germany., Jansson V; Department of Orthopaedic and Trauma Surgery, Ludwig Maximilians University Munich, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany., Günther KP; University Clinic Carl Gustav Carus, Center for Orthopaedic & Trauma Surgery, Technical University Dresden, Dresden, Germany.
Publikováno v:
EFORT open reviews [EFORT Open Rev] 2023 Jul 03; Vol. 8 (7), pp. 509-521. Date of Electronic Publication: 2023 Jul 03.