The Regulation of Wearable Medical Devices.
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[1] Elaine French-Mowat,et al. How are medical devices regulated in the European Union? , 2012, Journal of the Royal Society of Medicine.
[2] N Teow,et al. FDA Regulation of Medical Devices and Medical Device Reporting , 2013 .
[3] Aaron S Kesselheim,et al. Regulation of medical devices in the United States and European Union. , 2012, The New England journal of medicine.
[4] J. Ip. Wearable Devices for Cardiac Rhythm Diagnosis and Management. , 2019, JAMA.
[5] G. Norman,et al. Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices , 2016 .
[6] Study of the wearable cardioverter defibrillator in advanced heart‐failure patients (SWIFT) , 2017, Journal of cardiovascular electrophysiology.
[7] Julia E Mück,et al. Market and Patent Analyses of Wearables in Medicine. , 2019, Trends in biotechnology.
[8] J. A. Johnson,et al. FDA Regulation of Medical Devices , 2012 .
[9] A. Kesselheim,et al. Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China , 2013, PLoS medicine.