Improved clinical investigation and evaluation of high-risk medical devices:the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

Autor: Arjola Bano, Stefan James, Gero Viola, Enrico G. Caiani, Frank Rademakers, Felicitas Kühne, Elizabeth Macintyre, Michael Hahn, Per Kjærsgaard-Andersen, Stephan Windecker, Anett Ruszanov, T Melvin, Richard Holborow, Anne Lubbeke-Wolf, Rob Nelissen, Sabine Ettinger, Jan Szulc, Petra Schnell-Inderst, A G Fraser, Marieke Meijer, Harry van Vugt, Juan Antonio Blasco Amaro, Peter McCulloch, Loredana Simulescu, P Kjærsgaard-Andersen, Chris P Gale, Susana L F Cabaço, Christoph Stettler, Erik Kamenjasevic, Robert E Geertsma, Jantine W P M van Baal, Ola Rolfson, Michèle Meagher, Marina Torre, Sergio Buccheri, P Szymański, Polyxeni Vairami, Cinzia Cappiello, Alan Fraser, Thomas Wejs Møller, Lorenzo Gianquintieri, Joel Jakobsson, Lia Bally, Suzanne Halliday, Aldo P. Maggioni, Hannes Jarke, Christoph Ziskoven, Lotje A. Hoogervorst, Valentina Strammiello, Marianna Mastroroberto, Juan Carlos Rejón Parrilla, Joëlle M Hoebert, Ewout W. Steyerberg, David Epstein, Sarah Wieczorek, Claudia Wild, Jan D'hooge, Alexey Shiryaev, Erman Melikyan, Stefano Del Torso, James R. Smith, Sabina Hoekstra, Paola Laricchiuta, Andre Frenk, Niall MacAleenan, Piotr Szymański, Martin J Landray, Françoise Schlemmer, Elisabetta Zanon, Core-Md Investigators, Perla J Marang-van de Mheen, Amanda Tornsö, Tom Melvin, Ann-Sofie Sonne Holm-Schou, Eugenio Carrani, Kaisa Immonen, Cinzia Ceccarelli, Stefania Ceccarelli, Filippo Boniforti, R G H H Nelissen, Ria Mahon, Adamos Hadjipanayis, Georgios Siontis, Bas B.L. Penning de Vries, Christina Dimopoulou, Robert A. Byrne, Elisabetta Biasin, Maristella Matera, Laurna McGovern, Agnieszka Dobrzynska, Berthold Koletzko, Anton Vedder, P Piscoi, Daniel Prieto Alhambra, Gearóid McGauran, Adrian Ott

Publikováno v: Fraser, A G, Nelissen, R G H H, Kjærsgaard-Andersen, P, Szymański, P, Melvin, T, Piscoi, P & CORE-MD Investigators 2022, ' Improved clinical investigation and evaluation of high-risk medical devices : the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices) ', European Heart Journal-Quality of Care and Clinical Outcomes, vol. 8, no. 3, pp. 249–258 . https://doi.org/10.1093/ehjqcco/qcab059
EFORT Open Reviews, 6(10), 839-849. BRITISH EDITORIAL SOC BONE & JOINT SURGERY
EFORT Open Reviews
Fraser, Alan G; Nelissen, Rob G H H; Kjærsgaard-Andersen, Per; Szymański, Piotr; Melvin, Tom; Piscoi, Paul (2021). Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices). EFORT open reviews, 6(10), pp. 839-849. The British Editorial Society of Bone & Joint Surgery 10.1302/2058-5241.6.210081
Fraser, A G, Nelissen, R G H H, Kjærsgaard-Andersen, P, Szymański, P, Melvin, T & Piscoi, P 2021, ' Improved clinical investigation and evaluation of high-risk medical devices : the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices) ', EFORT Open Reviews, vol. 6, no. 10, pp. 839-849 . https://doi.org/10.1302/2058-5241.6.210081

In the European Union (EU), the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicin

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4c4cd329458895c5cdcfe189e80c2b53
https://portal.findresearcher.sdu.dk/da/publications/30f5f7b8-aa4a-4b17-926b-6efa3983bc20