Titlebook: Medical Devices; Improving Health Car Carlo Boccato,Sergio Cerutti,Joerg Vienken Book 2022 The Editor(s) (if applicable) and The Author(s),

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Definition and International Regulations for Medical Devicesl device” would offer significant benefits to the manufacturer, user, patient and to regulatory authorities. This can also support the global convergence of regulatory systems..This chapter aims to give a comprehensive description of the different regulations concerning the medical devices worldwide

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Lifecycle of Medical Devicestering and licensing the device in the different countries where the manufacturer would like to sell..This chapter considers all the above aspects and is completed with a case-study relevant to the development of a device for cardiac arrhythmia detection.

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Information and Communication Technology: Implications on Patient’s Privacy and Securityroduction of advanced medical devices and also define responsibilities of manufacturers and healthcare delivery organizations..The USA take care of data protection through the “Health Information Portability and Accountability Act (HIPAA).” However, there is currently no general federal legislation,

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Essentials of Innovation Theory for Medical Devicesenting and controlling the innovation process, from the early idea to the market introduction, is a prerequisite of a successful product life cycle. The knowledge of the different types of innovation processes and the respective barriers for a successful implementation supports decision-makers to overcome these barriers.

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Economic Perspectives: An Overviewcalculating the costs is not as simple as it might seem because costs can be tangible and intangible, direct and indirect, core and non-core costs. A thorough analysis of the perspective and the scope of costs is a prerequisite of efficiency and a starting point for the economic evaluation of medical devices.

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