Titlebook: Medical Devices and In Vitro Diagnostics; Requirements in Euro Christian Baumgartner,Johann Harer ,Jörg Schröttne Reference work 2023 Sprin

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The Notified Body: The Conformity Assessment Body for Medical Devices in Europe,ter, we present in detail what a Notified Body is in the sense of the aforementioned regulations and what special requirements are placed on designated notified bodies. We describe when a Notified Body is required for CE marking and what the main tasks of a Notified Body are in the conformity assess

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Risk Management for Medical Devices in Compliance with EN ISO 14971,its implementation is outlined. In addition, the individual elements of the risk management process are described and discussed in detail. All documents that are considered as evidence of the establishment of a complete risk management process are presented, and their necessary content is shown. The

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Safety Requirements for Medical Devices in Compliance with European Standards,es to comply with the state of the art and how it can be achieved. It also provides a brief overview of the safety requirements of the medical device regulations, with a focus on single fault conditions and the philosophy of integrated safety, together with an attempt to identify possible ways of pr

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Software as Medical Device in Europe,t topics are addressed, such as the European Data Protection Regulation or digital health applications on prescription and how, perhaps, the European approach could benefit from FDA approaches. This chapter provides a comprehensive overview on relevant requirements for software as a medical device a