The European Medical Device Regulation-What Biomedical Engineers Need to Know von Melvin, Tom

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Learning From Experience and Finding the Right Balance in the Governance of Artificial Intelligence and Digital Health Technologies von Gilbert, Stephen, Anderson, Stuart, Daumer, Martin, Li, Phoebe, Melvin, Tom, Williams, Robin

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The regulatory status of health apps that employ gamification von Freyer, Oscar, Wrona, Kamil J., de Snoeck, Quentin, Hofmann, Moritz, Melvin, Tom, Stratton-Powell, Ashley, Wicks, Paul, Parks, Acacia C., Gilbert, Stephen

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Can Apple and Google continue as health app gatekeepers as well as distributors and developers? von Sadare, Olamide, Melvin, Tom, Harvey, Hugh, Vollebregt, Erik, Gilbert, Stephen

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Large language model AI chatbots require approval as medical devices von Gilbert, Stephen, Harvey, Hugh, Melvin, Tom, Vollebregt, Erik, Wicks, Paul

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Continuous Improvement of Digital Health Applications Linked to Real-World Performance Monitoring: Safe Moving Targets? von Gilbert, Stephen, Pimenta, Andreia, Stratton-Powell, Ashley, Welzel, Cindy, Melvin, Tom

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Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature von Lübbeke, Anne, Combescure, Christophe, Barea, Christophe, Gonzalez, Amanda Inez, Tucker, Keith, Kjærsgaard-Andersen, Per, Melvin, Tom, Fraser, Alan G, Nelissen, Rob, Smith, James A

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New medical device regulations: the regulator's view von Melvin, Tom, Torre, Marina

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A European regulatory pathway for Tidepool loop following clearance in the United States? von Downey, Laura, O'Donnell, Shane, Melvin, Tom, Quigley, Muireann

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Evidence from clinical trials on high-risk medical devices in children: a scoping review von Guerlich, Kathrin, Patro-Golab, Bernadeta, Dworakowski, Paulina, Fraser, Alan G., Kammermeier, Michael, Melvin, Tom, Koletzko, Berthold

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Orphan and paediatric medical devices in Europe: recommendations to support their availability for on-label and off-label clinical indications von Melvin, Tom, Dooms, Marc M, Koletzko, Berthold, Turner, Mark A, Kenny, Damien, Fraser, Alan G, Gewillig, Marc, Jonker, Anneliene Hechtelt

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A millennial long March–July precipitation reconstruction for southern-central England von Wilson, Rob, Miles, Dan, Loader, Neil J., Melvin, Tom, Cunningham, Laura, Cooper, Richard, Briffa, Keith

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The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring von Marcus, Hani J., Ramirez, Pedro T., Khan, Danyal Z., Layard Horsfall, Hugo, Hanrahan, John G., Williams, Simon C., Beard, David J., Bhat, Rani, Catchpole, Ken, Cook, Andrew, Hutchison, Katrina, Martin, Janet, Melvin, Tom, Stoyanov, Danail, Rovers, Maroeska, Raison, Nicholas, Dasgupta, Prokar, Noonan, David, Stocken, Deborah, Sturt, Georgia, Vanhoestenberghe, Anne, Vasey, Baptiste, McCulloch, Peter

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Design, analysis and validation of left ventricular assist device von Antony, Martin, Tom, Melvin, Varghese, Jacob, Joseph, Sebin, Polachan, Sheen

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European expert recommendations on clinical investigation and evaluation of high‐risk medical devices for children von Guerlich, Kathrin, Patro‐Golab, Bernadeta, Barnacle, Alex, Baumann, Ulrich, Eicken, Andreas, Fraser, Alan G., Gruszfeld, Dariusz, Haas, Nikolaus A., Jonker, Anneliene H., Kammermeier, Michael, Kenny, Damien, Kolaček, Sanja, Lapatto, Risto, Maconochie, Ian, Mader, Silke, McGauran, Gearóid, Melvin, Tom, Muensterer, Oliver, Piscoi, Paul, Romano, Alberto, Saxena, Amulya K., Schneider, Dominik T., Turner, Mark A., Walle, Johan Vande, Koletzko, Berthold

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Author Correction: The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring von Marcus, Hani J., Ramirez, Pedro T., Khan, Danyal Z., Layard Horsfall, Hugo, Hanrahan, John G., Williams, Simon C., Beard, David J., Bhat, Rani, Catchpole, Ken, Cook, Andrew, Hutchison, Katrina, Martin, Janet, Melvin, Tom, Stoyanov, Danail, Rovers, Maroeska, Raison, Nicholas, Dasgupta, Prokar, Noonan, David, Stocken, Deborah, Sturt, Georgia, Vanhoestenberghe, Anne, Vasey, Baptiste, McCulloch, Peter

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Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices) von Fraser, A. G., Nelissen, R. G. H. H., Kjaersgaard-Andersen, P., Szymanski, P., Melvin, T., Piscoi, P.

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How to advance from minimally invasive coronary artery bypass grafting to totally endoscopic coronary bypass grafting: challenges in Europe versus United States of America von Algoet, Michiel, Melvin, Tom, Cerny, Stepan, Bonatti, Johannes, Singh, Sandeep, Folliguet, Thierry, Modi, Paul, Franke, Ulrich, Gianoli, Monica, Agnino, Alfonso, Casselman, Filip, Oosterlinck, Wouter

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Careers in Science and Healthcare - How changes to medical device regulation have increased training needs von Melvin, Tom

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Evidence from clinical trials on high-risk medical devices in children von Guerlich, Kathrin, Patro-Golab, Bernadeta, Dworakowski, Paulina, Fraser, Alan G, Kammermeier, Michael, Melvin, Tom, Koletzko, Berthold

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