The European Medical Device Regulation–What Biomedical Engineers Need to Know by Tom Melvin

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

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

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

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

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

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Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers by Lotje A Hoogervorst, Yijun Ren, Tom Melvin, Ashley A Stratton-Powell, Anne Lübbeke, Robert E Geertsma, Alan G Fraser, Rob G H H Nelissen, Enrico G Caiani, Perla J Marang-van de Mheen

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Correction: Large simple randomized controlled trials—from drugs to medical devices: lessons from recent experience by Sergio Buccheri, Stefan James, Marion Mafham, Martin Landray, Tom Melvin, Jonas Oldgren, Richard Bulbulia, Louise Bowman, Lotje Anna Hoogervorst, Perla J. Marang-van de Mheen, Peter Juni, Peter McCulloch, Alan G. Fraser

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Large simple randomized controlled trials—from drugs to medical devices: lessons from recent experience by Sergio Buccheri, Stefan James, Marion Mafham, Martin Landray, Tom Melvin, Jonas Oldgren, Richard Bulbulia, Louise Bowman, Lotje Anna Hoogervorst, Perla J. Marang-van de Mheen, Peter Juni, Peter McCulloch, Alan G. Fraser

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